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Quality-assurance program for the improvement of morbidity during the first three postpartum days following episiotomy and perineal trauma
Abstract
Objective: To evaluate implementation of an analgesic protocol for the management of pain caused by perineal trauma. Design: Quality-assurance program (QAP) with a closed loop audit. Setting: Postpartum ward in a referral perinatal centre. Population: Postpartum women with perineal trauma after vaginal delivery. Methods: A multimodal analgesic protocol was implemented (Phase 2) and data were collected before (Phase 1) and after implementation (at 1 year [Phase 3] and at 3 years [Phase 4]). Results: Phase 1 showed that perineal injury caused significant pain. When comparing Phases 3 and 4 to patients sutured in Phase 1, there was a significant decrease in immediate and worst pain scores on postpartum Days 1–3. More patients reported no difficulty in micturition and in defecation and more patients received analgesics compared to before protocol implementation. Conclusion: Introduction of an analgesic regimen for relief of postpartum perineal pain achieved a high degree of compliance and resulted in a sustained improvement in pain control and reduction of short-term morbidity.
... Durante el puerperio hospitalario, en el Patrón 1 Percepción -Manejo de la Salud nosotros encontramos que las mujeres con desgarro no tenían dificultades en sus actividades cotidianas y aquellas con episiotomía sí (nos referimos a su movilidad para caminar, sentarse, levantarse e incluso alimentar a su bebé). La información aportada por otros estudios confirma que esta práctica genera un dolor en las primeras 24-48 horas que repercute en la movilidad, reduciéndola (14) . Las mujeres a las que no se les practicó episiotomía manifiestan un mayor bienestar general, el dolor a la deambulación es prácticamente inexistente y se sientan con mayor comodidad (15) . ...
... En cuanto al Patrón 2 Nutricional Metabólico, en el puerperio clínico comprobamos que las mujeres con desgarro no presentaban molestias en la zona del periné ni problemas para alimentar a sus hijos. No obstante, otros estudios indican que la alteración del Patrón 1 puede a su vez afectar a éste, ya que al caminar, cambiar de posición y sentarse, hay una exacerbación del dolor que dificulta la lactancia materna (14,15) . ...
... Esta técnica es un factor de riesgo para la incontinencia urinaria, junto con el uso de fórceps o un expulsivo prolongado, mas no influye en los diferentes tipos de incontinencia urinaria (22) . Otros estudios determinan que el dolor que genera puede afectar a la defecación, causando estreñimiento, y a la micción, causando dificultad para la misma (14,15) . ...
Objective:
Analyse if there is any difference in recovery rate according to their puerperium stage depending on perineal lesion.
Material and method:
Prospective longitudinal descriptive quantitative study, following the Marjory Gordon’s Functional Health Patterns. Data collection will be performed in three phases (immediate, clinical and remote puerperium), through semi-structured interview completed in first instance in a face-to-face interview and phone call interview at 10 and 30 days, respectively.
Results:
In Spain there is an episiotomy, induction and assisted delivery rate much higher than recommended. Episiotomy technique lead to significant tear (16,7%) in this study. During immediate puerperium, women who were practiced an episiotomy shown mobility difficulties (p=0,0005), elimination (p=0,0007), baby care (p=0,015), rest (p=0,15) and perceived pain (p=0,005), whereas in the clinical puerperium are affected only mobility (p=0,05), elimination (p=0,042) and perceived pain (p=0,006). After 30 days, remote puerperium, there is not statistical significant differences in both groups. More research is needed to confirm these facts as well as provide new knowledge.
Conclusions:
Episiotomy produce more negative effects than spontaneous tears at the immediate and clinical puerperium of women. Pain produced by this technique as a short, medium and long term limit many daily activities of women.
... In addition to gaps in immediate care, subsequent postpartum management is unlikely to be based on robust evidence or the degree of trauma sustained. Despite pain being experienced by hundreds of thousands of women in the UK, and many more worldwide and the availability of evidence-based guidance for postnatal management [3,111213 , the identification and management of longer-term perineal morbidity such as pain, dyspareunia, wound infection and haematoma, has not been a high priority in practice or research. ...
... ▪ Reading material for independent study and self directed learning ▪ Copies of the RCOG and postnatal perineal care guidelines and perineal pain relief protocol [5,12,13] ▪ A formal workshop which will provide information on the principles of recognition and management of perineal trauma, surgical skills and simulated handson experience for the second degree & episiotomy repair ▪ An interactive CD-ROM to help participants refresh core information, and maintain competency ▪ An Objective Structured Assessment of Training (OSAT) proforma which will form part of the participants initial and ongoing assessment process, to be completed within 3 months of the training intervention ▪ A leaflet for all women who sustain sutured perineal trauma to promote self-management of their perineal trauma, and their general health and wellbeing , and advice on who to contact if they have any concerns ...
... Baseline data will be collected from each pair of units by undertaking a prospective clinical audit (Audit 1) over a period of around one month (although the precise length of time may be shorter, depending on the size of the units recruited). The aim of the first audit (Audit 1) is to assess practice prior to any intervention, against quality standards for perineal management [5,12,13]. Women who give birth during the same time period, who have an episiotomy or sustain a second degree perineal tear, will be invited to complete questionnaires at 10-12 days (Survey 1A) and three months (Survey 1B) postpartum to monitor immediate and longer-term impact on health and other outcomes. ...
The Perineal Assessment and Repair Longitudinal Study (PEARLS) is a national clinical quality improvement initiative designed to improve the assessment and management of perineal trauma. Perineal trauma affects around 85% of women who have a vaginal birth in the UK each year and millions more world-wide. Continuous suturing techniques compared with traditional interrupted methods are more effective in reducing pain and postnatal morbidity, however they are not widely used by clinicians despite recommendations of evidence based national clinical guidelines. Perineal suturing skills and postnatal management of trauma remain highly variable within and between maternity units in the UK as well as worldwide. Implementation of a standardised training package to support effective perineal management practices could reduce perineal pain and other related postnatal morbidity for a substantial number of women.
PEARLS is a matched pair cluster trial, which is being conducted in maternity units across the UK. Units within a matched pair will be randomised to implement the study intervention either early or late in the study period. The intervention will include the cascading of a multi-professional training package to enhance midwifery and obstetric skills in the assessment, repair and postnatal management of perineal trauma. Women who have had an episiotomy or second degree perineal tear will be eligible for recruitment. Prior to developing the intervention and deciding on study outcomes, a Delphi survey and a consensus conference were held to identify what women, who previously suffered perineal trauma during childbirth, considered to be important outcomes for them. Findings from this preliminary work (which will be reported elsewhere) and other outcomes including women's experiences of perineal pain and pain on activity, breastfeeding uptake and duration and psychological well-being as assessed using the Edinburgh Postnatal Depression Scale (EPDS) will be assessed at 10 days and three months post-birth.
Implementation of evidence-based perineal assessment and management practices, could lead to significantly improved physical and psychological health outcomes for women in the UK and world-wide.
PEARLS is registered with the Current Controlled Trials Registry (no: ISRCTN28960026). NIHR UKCRN portfolio no: 4785.
... Episiotomy pain negatively affects daily activities such as movement, urination, defecation and lactation, especially during the first 3 days postpartum (Yanık & Ertem, 2020). In previous studies, 20-25% of women felt pain in the perineal region that lasted for the first 2 weeks after giving birth and undergoing an episiotomy, and 10% felt it for at least 3 months (Beleza et al., 2017;Ghosh et al., 2004). The main goal then is to improve quality What does this paper contribute to the wider global community? ...
Aims and Objectives
To evaluate the effectiveness of cold application methods in reducing postpartum episiotomy pain.
Background
Many women suffer from pain after giving birth due to an episiotomy. This prolonged pain affects their daily lives as they recover. Various methods can help alleviate this pain; however, the effects of cold application specifically are still under discussion.
Design
Systematic review and meta-analysis were used.
Methods
In this review, we investigated studies from the CINAHL, PubMed, Google Scholar and Science Direct databases that met PICOS inclusion criteria. We also assessed the studies' methodological quality with the JADAD and JBI checklists. This study was performed based on the Guidelines of Systematic Reporting of Examination presented in the PRISMA checklist (Appendix S1). The search protocol has been registered at the PROSPERO International Prospective Register of Systematic Reviews.
Results
A total of seven published studies including 700 total participants were included in this review. Various cold application methods (cold gel pack/pad, crushed ice gel pad, ice pack) significantly reduced the pain after an episiotomy. Ice packs in particular did not significantly differ from lavender oil and acupressure in reducing pain after an episiotomy.
Conclusions
Cold application methods can be an effective, non-pharmacological midwifery and nursing intervention to reduce pain after an episiotomy.
Relevance to clinical practice
The use of cold application methods to reduce pain after episiotomy may reduce the need for pharmacological medication in women due to the reduction in pain in the perineum.
La prise en charge optimale de la douleur est déterminante pour permettre une réhabilitation dans la période péri-opératoire. Ces principes, bien connus en chirurgie, s’appliquent aux patientes après un accouchement par césarienne ou un accouchement par voie basse (AVB). En effet, si la césarienne a longtemps été considérée comme un modèle de douleur aiguë « reproductible », les douleurs aiguës après AVB ont été en grande partie sous-estimées, voire méconnues, et leur prise en compte en suites de couches est relativement récente. Les douleurs périnéales sont pourtant très fréquentes: leur durée et leur intensité sont corrélées à la gravité des lésions. Elles représentent une véritable gêne à la réhabilitation post-partum.
Pour le praticien, la réhabilitation post-partum centrée sur des stratégies analgésiques adaptées, devra également tenir compte des spécificités de la période post-partum que sont la facilitation de la relation mère-enfant, l’allaitement et la mise en oeuvre des soins au nouveau-né. Par-delà la réhabilitation post-partum immédiate, la prise en compte et le traitement de la douleur aiguë permettent également de prévenir l’émergence de douleurs chroniques et de syndromes dépressifs à distance de l’accouchement. L’incidence de ces derniers, non négligeable, est mieux connue aujourd’hui et semble indépendante du mode d’accouchement.
Perineal and proctologic surgery is well known as very painful. The apparition of new specific needles, long acting and less toxic local anaesthetics and neurostimulation allowed reconsidering some old forgotten techniques. Those blocks appear really useful to optimize multimodal postoperative analgesia and postoperative rehabilitation. After anatomic review, authors describe perineal regional anaesthesia and discuss about main indications and advantages, in the eyes of their experience and bibliographic review.
The study was carried out to compare the analgesic effect of diclofenac sodium and indomethacin suppositories for management of right mediolateral episiotomy repair.
A total of 70 patients who gave birth vaginally with right mediolateral episitomy were randomly assigned to receive 100 mg diclofenac sodium suppositories/day (G1, n = 35) or 100 mg indomethacin supposotories/day (G2, n = 35) after episiotomy repair and postpartum for three days. Pain ratings were recorded before, the first hour and 24 hours after medication. The verbal rating scale (VRS) and visual analog scale (VAS) were used for pain recording. The independent T test, Mann-Whitney U and Wilcoxon rank test were used for statistical analysis and Spearman correlation analysis was used for comparison between VRS and VAS.
Diclofenac sodium was a more effective analgesic than indomethacin suppositories for right mediolateral episiotomy pain. For G1 the first hour VRS was 2.6 +/- 0.5 points and VAS 4.9 +/- 0.8 points; for G2 the first hour VRS was 3.4 +/- 0.6 points VAS 6.6 +/- 1.2 points; this difference was statistically significant (p < 0.05, Mann-Whitney U test). For G1 at the 24th hour VRS was 1.2 +/- 0.4 points and VAS 2.4 +/- 0.9 points; for G2 at the 24th hour VRS was 2 +/- 0.7 points and VAS was 3.4 +/- 1.3 points; the difference was statistically significant (p < 0.05, Mann-Whitney U test). The first and 24th hour pain scores (VAS1-VAS24, VRS1-VRS24) were decreased dramatically for both groups (p < 0.05, Wilcoxon rank test). A positive correlation was obtained between the first and 24th hour VRS and VAS by Spearman correlation analysis (r(s) = 0.9, n = 70, p = 0.000).
The two analgesics were effective after episiotomy repair, however diclofenac sodium suppositories may be the preferred choice because they were more effective.
After briefly expounding the principles of an audit, this article focusses on the role of obstetric audit and how it can influence, and even shape, obstetric anaesthetic practice. The impact may be on service delivery, anaesthetic practice or the generation of new information. The relevance of maternal mortality reporting and of obstetric haemorrhage audit to anaesthetic practice is used to illustrate these concepts. Further examples include how different types of audit of pregnancy outcome, obstetric practice or areas of cross-interest to both obstetricians and anaesthetists are used by anaesthetists to evaluate health-care delivery, their own practices and to generate new audit and research agendas. Audits drive change and, hopefully, improvements that continue to make pregnancy a safer and more satisfying event for the mother and child.
One thousand women were allocated at random to one of two perineal management policies, both intended to minimise trauma during spontaneous vaginal delivery. In one the aim was to restrict episiotomy to fetal indications; in the other the operation was to be used more liberally to prevent perineal tears. The resultant episiotomy rates were 10% and 51% respectively. An intact perineum was more common among those allocated to the restrictive policy. This group experienced more perineal and labial tears, however, and included four of the five cases of severe trauma. There were no significant differences between the two groups either in neonatal state or in maternal pain and urinary symptoms 10 days and three months post partum. Women allocated to the restrictive policy were more likely to have resumed sexual intercourse within a month after delivery. These findings provide little support either for liberal use of episiotomy or for claims that reduced use of the operation decreases postpartum morbidity.
Objective:
Our purpose was to compare consequences for women of receiving versus not receiving median episiotomy early and 3 months post partum on the outcomes perineal pain, urinary and pelvic floor functioning by electromyography, and sexual functioning and to analyze the relationship between episiotomy and third- and fourth-degree tears.
Study design:
A secondary cohort analysis was performed of participants within a randomized clinical trial, analyzed by type of perineal trauma and pain, pelvic floor, and sexual consequences of such trauma, while controlling for trial arm. The study was conducted in three university or community hospitals; 356 primiparous and 341 multiparous women were studied.
Results:
Early and 3-month-postpartum perineal pain was least for women who gave birth with an intact perineum. Spontaneous perineal tears were less painful than episiotomy. Sexual functioning was best for women with an intact perineum or perineal tears. Postpartum urinary and pelvic floor symptoms were similar in all perineal groups. At 3 months post partum those delivered with an intact perineum had the strongest pelvic floor musculature, those with episiotomy the weakest. Among primiparous women third- and fourth-degree tears were associated with median episiotomy (46/47). After forceps births were removed and 21 other variables potentially associated within such tears were controlled for, episiotomy was strongly associated with third- and fourth-degree tears (odds ratio +22.08, 95% confidence interval 2.84 to 171.53). Physicians using episiotomy at high rates also used other procedures, including cesarean section, more frequently.
Conclusion:
Perineal and pelvic floor morbidity was greatest among women receiving median episiotomy versus those remaining intact or sustaining spontaneous perineal tears. Median episiotomy was causally related to third- and fourth-degree tears. Those using episiotomy at the highest rates were more likely use other interventions as well. Episiotomy use should be restricted to specified fetal-maternal indications.
To evaluate the risk of gastrointestinal and operative site bleeding associated with the use of parenteral ketorolac tromethamine.
Postmarketing surveillance inception cohort study.
A total of 35 hospitals throughout the Philadelphia, Pa, region, 1991 to 1993.
Patients administered 10,272 courses of parenteral ketorolac therapy were compared with patients administered 10,247 courses of a parenteral opiate who were matched to the ketorolac patients by hospital, admitting service, and date of initiation of study drug.
Medical records were reviewed for demographics, medical history, doses and duration of study drug, various aspects of the hospital course including surgery and concomitant medications, and adverse events.
The multivariate adjusted odds ratio (OR) comparing ketorolac with opiates for gastrointestinal bleeding was 1.30 (95% confidence interval [CI], 1.11 to 1.52); for operative site bleeding, the OR was 1.02 (95% CI, 0.95 to 1.10). The OR was elevated further in subjects 75 years of age or older for both gastrointestinal bleeding (OR = 1.66; 95% CI, 1.23 to 2.25) and operative site bleeding (OR = 1.12; 95% CI, 0.94 to 1.35). A dose-response relationship was evident between average daily ketorolac dose and both gastrointestinal bleeding and operative site bleeding (trend test P < .001 for both). When analgesic therapy lasted 5 or fewer days, ketorolac was associated with only a small increased risk of gastrointestinal bleeding (OR = 1.17; 95% CI, 0.99 to 1.30); when therapy was prolonged beyond 5 days, the OR was 2.20 (95% CI, 1.36 to 3.57). The association of ketorolac with operative site bleeding was not affected by duration of therapy.
The overall associations between ketorolac use and both gastrointestinal bleeding and operative site bleeding are small. However, the risk associated with the drug is larger and clinically important when ketorolac is used in higher doses, in older subjects, and for more than 5 days. Improving physicians' prescribing practices by limiting the dose and duration of ketorolac use, especially in the elderly, should enhance its overall risk-benefit balance.
The issue of prescription of analgesics during lactation is clinically important but also complex. Most of the information available is based on single dose or short term studies, and for many drugs only a single or a few case reports have been published. As great methodological problems exist in the assessment of possible adverse drug reactions in neonates and infants, there is limited knowledge about the practical impact of the, often very low, concentrations found. Nevertheless, some recommendations can be made. Breast-feeding during maternal treatment with paracetamol (acetaminophen) should be regarded as being safe. Short term use of nonsteroidal anti-inflammatory drugs seems to be compatible with breast-feeding. For long term treatment, short-acting agents without active metabolites, such as ibuprofen, should possibly be preferred. The use of aspirin (acetylsalicylic acid) in single doses should not pose any significant risks to the suckling infant. Use of codeine is probably compatible with breast-feeding, although the effects of long term exposure have not been fully elucidated. For propoxyphene, it seems unlikely that the suckling infant will ingest amounts that will cause any detrimental effects during short term treatment. However, it cannot be excluded that significant amounts of the metabolite norpropoxyphene may arise in the suckling infant during long term exposure. Treatment of the mother with single doses of morphine or pethidine (meperidine) is not expected to cause any risk for the suckling infant. Repeated administration of pethidine, in contrast to morphine, affects the suckling infant negatively. Thus, morphine should be preferred in lactating mothers. However, during long term treatment with morphine, the importance of uninterrupted breast-feeding should be assessed on an individual basis against the potential risk of adverse drug effects in the infant. If it is decided to continue breast-feeding the infant should be observed for possible adverse effects. In general, if treatment of a lactating mother with an analgesic drug is considered necessary, the lowest effective maternal dose should be given. Moreover, infant exposure can be further reduced if breast-feeding is avoided at times of peak drug concentration in milk. As breast milk has considerable nutritional, immunological and other advantages over formula milk, the possible risks to the infant should always, and on an individual basis, be carefully weighed against the benefits of continuing breast-feeding.
Pain from episiotomy or tearing of perineal tissues during childbirth is often poorly treated and may be severe. This randomized double-blind controlled trial was performed to compare the effectiveness, side effects and cost of, and patient preference for, 2 analgesics for the management of postpartum perineal pain.
A total of 237 women who gave birth vaginally with episiotomy or a third- or fourth-degree tear between August 1995 and November 1996 at a tertiary-level teaching and referral centre for obstetric care in Vancouver were randomly assigned to receive either ibuprofen (400 mg) (n = 127) or acetaminophen (600 mg) with codeine (60 mg) and caffeine (15 mg) (Tylenol No. 3) (n = 110), both given orally every 4 hours as necessary. Pain ratings were recorded before the first dose and at 1, 2, 3, 4, 12 and 24 hours after the first dose on a 10-cm visual analogue scale. Side effects and overall opinion were assessed at 24 hours.
Ibuprofen and acetaminophen with codeine had similar analgesic properties in the first 24 hours post partum (mean pain rating 3.4 and 3.3, mean number of doses in 24 hours 3.4 and 3.3, and proportion of treatment failures 13.8% [16/116] and 16.0% [16/100] respectively). Significantly fewer subjects in the ibuprofen group than in the acetaminophen with codeine group experienced side effects (52.4% v. 71.7%) (p = 0.006). There were no significant differences in overall patient satisfaction between the 2 groups. The major determinant of pain intensity was forceps-assisted delivery. Overall, 78% of the treatment failures were in women with forceps-assisted deliveries.
Since the 2 analgesics were rated similarly, ibuprofen may be the preferred choice because it is less expensive and requires less nursing time to dispense. Further studies need to address improved analgesia for women with forceps-assisted deliveries.
Aim of the study: The course of pain and the incidence/severity of side effects from analgesics were evaluated for the first five postoperative days in 135 consecutive patients after caesarean section. Methods: The analgesic regimen was based on the regular administration of a combination of ketoprofen (50 mg.6 h-1), paracetamol and an opioid (subcutaneous, intravenous PCA or intrathecal injection). Ketoprofen was discontinued on day 3 while paracetamol and propoxyphene were still available on demand for two additional days. Overall, analgesia, using a visual analogue scale, was excellent both at rest and on movement. Patients in whom ketoprofen was contraindicated (13%) had significantly higher pain scores at rest. No major maternal or neonatal side effect occurred. Maternal satisfaction was very high. Conclusion: This triple analgesic therapy including a nonsteroidal anti-inflammatory drug proved to be a very efficient way to control post- caesarean pain, led to a small consumption of morphine in patients using PCA and was associated with great compliance and satisfaction of patients.
Episiotomy is a widely-done intervention in childbirth,
regardless of poor scientific evidence of its benefits. This
randomised controlled trial compares selective with routine
use of a mediolateral episiotomy for women having first and
second deliveries in 8 public maternity units in Argentina.
2606 women participated; 1555 were nulliparous (778 in
the selective group and 777 in the routine group) and 1051
primiparous (520 in the selective group and 531 in the routine
group). The two interventions compared were selective (limited
to specified maternal or fetal indications), and routine
episiotomy (following the hospital's previous policy).
Episiotomy was done in 30-1% of deliveries in the selective,
and 82.6% in the routine group. The main outcome measure
was severe perineal trauma. Severe perineal trauma was
uncommon in both groups but was slightly less frequent in the
selective group (1.2% vs 1-5%). Anterior perineal trauma was
more common in the selective group but posterior perineal
surgical repair, perineal pain, healing complications, and
dehiscence were all less frequent in the selective group.
Routine episiotomy should be abandoned and episiotomy
rates above 30% cannot be justified.
The relief of post-episiotomy pain was investigated in three groups of women, ranked ASA 1 or 2, using either a single dose of 400 mg of ibuprofen (n = 31), or 1 g of paracetamol (n = 28) or placebo (n = 31). Pain intensity was assessed with a visual analogic scale, a verbal scale and pain relief scores after half an hour, 1, 2, 3, 4, 5 and 6 h. The day after treatment, patients rated the quality of pain relief, and were asked whether they wished to take again the same drug for the same type of pain. In the placebo and paracetamol groups, respectively 22 and 16 patients asked for usual treatment before the sixth hour, whereas only 5 did so in the ibuprofen group (p < 0.001). Ibuprofen was more effective after one hour than either of the other two drugs, whatever the scale or parameter used. In the ibuprofen group, the lower pain score was observed at the third hour. At six hours, the pain score did not differ from that three hours carlier. On the day after treatment, 22 patients from the ibuprofen group considered pain relief to have been good or excellent, versus 8 and 5 in the paracetamol and placebo groups respectively (p < 0.001). Similarly, 24 patients from the ibuprofen group would accept the same drug again for the same type of pain, as opposed to 8 and 5 from the paracetamol and placebo groups respectively (p < 0.01). The only side-effect reported was abdominal pain in one patient (placebo group). Therefore, ibuprofen at a dose of 400 mg can be considered as an effective oral analgesic for post-episiotomy pain. A difference, if any, between paracetamol and placebo could not be observed in this study.
The issue of prescription of analgesics during lactation is clinically important but also complex. Most of the information available is based on single dose or short term studies, and for many drugs only a single or a few case reports have been published. As great methodological problems exist in the assessment of possible adverse drug reactions in neonates and infants, there is limited knowledge about the practical impact of the, often very low, concentrations found. Nevertheless, some recommendations can be made.
Breast-feeding during maternal treatment with paracetamol (acetaminophen) should be regarded as being safe. Short term use of nonsteroidal anti-inflammatory drugs seems to be compatible with breast-feeding. For long term treatment, short-acting agents without active metabolites, such as ibuprofen, should possibly be preferred. The use of aspirin (acetylsalicylic acid) in single doses should not pose any significant risks to the suckling infant.
Use of codeine is probably compatible with breast-feeding, although the effects of long term exposure have not been fully elucidated. For propoxyphene, it seems unlikely that the suckling infant will ingest amounts that will cause any detrimental effects during short term treatment. However, it cannot be excluded that significant amounts of the metabolite norpropoxyphene may arise in the suckling infant during long term exposure.
Treatment of the mother with single doses of morphine or pethidine (meperidine) is not expected to cause any risk for the suckling infant. Repeated administration of pethidine, in contrast to morphine, affects the suckling infant negatively. Thus, morphine should be preferred in lactating mothers However, during long term treatment with morphine, the importance of uninterrupted breast-feeding should be assessed on an individual basis against the potential risk of adverse drug effects in the infant. If it is decided to continue breast-feeding the infant should be observed for possible adverse effects.
In general, if treatment of a lactating mother with an analgesic drug is considered necessary, the lowest effective maternal dose should be given. Moreover, infant exposure can be further reduced if breast-feeding is avoided at times of peak drug concentration in milk. As breast milk has considerable nutritional, immunological and other advantages over formula milk, the possible risks to the infant should always, and on an individual basis, be carefully weighed against the benefits of continuing breast-feeding.
This study examines the underlying determinants of nurses’ behaviour regarding the conduct of pain assessments One hundred nurses in a variety of health care facilities were invited to complete an Attitude Intention Questionnaire based upon the theory of planned action which is an extension of the theory of reasoned action Results provide some support for the theory of planned action, as nurses’ intention to conduct pain assessment was shown to be predicted by attitude, subjective norms and perceived control, although the latter was the only variable to make an independent contribution to intention Additional support for the importance of perceived control was provided by the analysis of ‘intenders’ and ‘non-intenders’(to conduct pain assessments), as perceived control was the only variable which differed significantly between the groups The findings are consistent with earlier studies which showed that the variables in the theory of planned behaviour provided reasonably accurate predictions of behavioural intention
SummaryA systematic review of the 14 relevant controlled trials was conducted because there is no agreement about the choice of material and technique for repair of perineal trauma sustained during childbirth. Derivatives of polyglycolic acid (marketed as Dexon and Vicryl) appear to be the absorbable material of choice for both deep and skin closure. Compared with catgut their use is associated with about a 40% reduction in short-term pain and need for analgesia. The main drawback is that some material often needs removal during the puerperium. Glycerol-impregnated catgut is ruled out because of its link with longterm dyspareunia. Compared with the non-absorbable materials (silk and nylon) polyglycolic acid skin sutures were associated with less shortterm perineal pain, and had no clear disadvantages. Continuous, subcuticular stitching appears preferable to interrupted, transcutaneous suturing, particularly in terms of perineal pain in the early puerperium.
To estimate the analgesic effect of ibuprofen and to test whether codeine and caffeine enhance its effect on post-surgical pain.
Systematic overview of the literature and meta-analysis of published randomised, controlled trials.
Ibuprofen is effective in dental pain, episiotomy pain and other post-operative pain. There is a dose response relationship over the range 50-400 mg. The difference in total pain-relief score relative to placebo was 19-31%. On average, patients were over three times more likely to obtain moderate to excellent pain relief with ibuprofen than with placebo (response-rate ratio = 3.45) and the number needed to treat was 2.44. Codeine 60 mg enhanced the analgesic effect of ibuprofen 400 mg by about 8% in the total pain-relief scale, but it also increased its adverse effects. The additive effect of caffeine was inconsistent.
Ibuprofen is an effective analgesic in post-operative pain. Codeine 60 mg adds to the analgesic effect of ibuprofen 400 mg. Any additive caffeine effect requires validation.
In a double-blind, randomized study, epidural infusions of low-dose morphine (0.2 mg/h) combined with low-dose bupivacaine (10 mg/h) were compared with epidural infusions of low-dose morphine (0.2 mg/h) alone for postoperative analgesia at rest and during mobilization and cough in 24 patients after elective major abdominal surgery. All patients in addition received systemic piroxicam (20 mg daily). No significant differences were observed between the groups at any assessment of pain at rest (P greater than 0.05), whereas pain in the morphine/bupivacaine group was significantly reduced during mobilization from the supine into the sitting position 12 and 30 h after surgical incision and during cough 8, 12, and 30 h after surgical incision (P less than 0.05). We conclude, that low-dose epidural bupivacaine potentiates postoperative low-dose epidural morphine analgesia during mobilization and cough. Evaluation of postoperative analgesic regimens should include assessment of pain during various activities as different analgesics may have differential effects on pain at rest and during mobilization.
A new sequential test has been used to compare the effect of paracetamol and placebo on uterine cramping. Paracetamol was significantly superior to placebo at the 5% level. 75 patients were included in the trial, whereas in a fixed sample study 90 patients would have been required to obtain the same significance level and power.
The magnitude of the difference in treatment effect was estimated following the sequential test. In addition to the effect on uterine pain, which was the primary variable, the effect on episiotomy pain was also estimated. Paracetamol was also superior to placebo against the episiotomy pain.
The influence of episiotomy was evaluated in a quasi-randomized follow-up study. In 193 primiparas with spontaneous vaginal delivery, postpartum perineal pain and insufficiency symptoms and their duration were evaluated by means of a questionnaire, 15-24 months post partum. Information about the birth and any complications was obtained from the medical records. On comparing the 85 primiparas delivered by midwives who had a low episiotomy rate (mean 21%) versus the 61 primiparas delivered by midwives with a medium episiotomy rate (mean 34%) and the 41 delivered by midwives with a high episiotomy rate (mean 70%), no differences were found regarding postpartum perineal pain and insufficiency symptoms. Postpartum perineal pain symptoms were significantly correlated to the duration of the second stage of labor, irrespective of the episiotomy rate of the midwife in charge, or of the use of episiotomy.
The authors review the frequency of reporting and severity of perineal pain in the post-partum period after episiotomy. The usage and efficacy of available analgesia is discussed.
A systematic review of the 14 relevant controlled trials was conducted because there is no agreement about the choice of material and technique for repair of perineal trauma sustained during childbirth. Derivatives of polyglycolic acid (marketed as Dexon and Vicryl) appear to be the absorbable material of choice for both deep and skin closure. Compared with catgut their use is associated with about a 40% reduction in short-term pain and need for analgesia. The main drawback is that some material often needs removal during the puerperium. Glycerol-impregnated catgut is ruled out because of its link with long-term dyspareunia. Compared with the non-absorbable materials (silk and nylon) polyglycolic acid skin sutures were associated with less short-term perineal pain, and had no clear disadvantages. Continuous, subcuticular stitching appears preferable to interrupted, transcutaneous suturing, particularly in terms of perineal pain in the early puerperium.
Perineal tissue injury and uterine cramping within the first 24-48 hours after vaginal delivery are established models for studying pain relief. In this study, information was gathered from prospective, randomized investigations comparing the safety and efficacy of several oral analgesics. Nonsteroidal antiinflammatory drugs (NSAIDs) have been found consistently to be more useful than a placebo or acetaminophen. As compared with aspirin, the newer NSAIDs had a more delayed onset of action but required fewer doses. Mild analgesics were usually all that was necessary, and a combination with codeine was usually unnecessary. Side effects and breast milk concentrations of the drugs were negligible for this short-term therapy. Although no drug was found to be preferable to the others, aspirin and ibuprofen were the least expensive.
Three methods of episiotomy repair were randomly assigned after 900 consecutive deliveries. The three procedures were: (1) continuous No. 00-plain catgut in the vagina; No. 00-plain catgut interrupted stitches in the perineal muscles and fascia, and No. 00-nylon interrupted stitches in the skin. (2) The same technique as in (1), but with No. 0-polyglycolic acid (Dexon) in all layers. (3) The suture material as in (2), but used with a subcuticular technique. The women treated with method 3 reported statistically significant less pain and disabilities in the early puerperium. Three months after delivery 262 women (33%) still had perineal complaints which could be directly related to the episiotomy in 25% (8% of total number). The group treated with method 3 had the best long-term results and we conclude that the subcuticular technique using polyglycolic acid should be the method of choice.
Our purpose was to evaluate the analgesic efficacy of single oral doses of ketoprofen 25, 50, and 100 mg compared with aspirin 650 mg and placebo in the relief of moderate to severe postepisiotomy, uterine cramping, or cesarean section pain. One hundred and fifty-six patients participated in a randomized, double-blind, stratified, parallel-group study. They were observed over a six-hour period by one nurse-observer. Several of the standard summary measures of analgesia were derived from the interview data, including the sum of pain intensity differences (SPID) and the sum of the hourly relief values (TOTAL). The study showed significant differences between aspirin and placebo for four-hour SPID and several other parameters and between ketoprofen at all dose levels and placebo for the four- and six-hour SPID and many other parameters. The two higher doses of ketoprofen were significantly more effective than aspirin as as assessed by the four- and six-hour SPID, TOTAL, and other summary measures. The low dose of ketoprofen, although not significantly different from aspirin for SPID and TOTAL, showed a significantly faster onset of relief and had a better global rating. This study suggests that 50 mg of ketoprofen may be the clinical dose of choice as an analgesic. There were no adverse effects reported.
The benefits and risks of episiotomy in labor and delivery as recorded in the English language literature in over 350 books and articles published since 1860 are reviewed and analyzed. Episiotomy is performed in over 60 per cent of all deliveries in the United States and in a much higher per cent of primigravidas. Yet, there is no clearly defined evidence for its efficacy, particularly for routine use. In addition, although poorly studied, there is evidence that postpartum pain and discomfort are accentuated after episiotomy, and serious complications, including maternal death, can be associated with the procedure. Therefore, carefully designed controlled trials of benefit and risk should be carried out on the use of episiotomy.
Episiotomy is a very common operation but little is known of its short-term or long-term morbidity.A prospective study was designed to record postpartum perineal discomfort and to investigate the presence and persistence of dyspareunia following episiotomy in 140 primigravidae. A comparison was made between those whose perineal skin was sutured with a subcuticular polyglycolic acid (;Dexon') stitch and those sutured with interrupted black silk stitches.Patients sutured with subcuticular ;Dexon' had significantly less perineal discomfort on the third, fourth, and fifth postpartum days. Patients who had epidural analgesia in labour had significantly more pain during the first five postpartum days irrespective of the suture material used.The timing of first coitus after delivery did not influence the presence or persistence of dyspareunia. Dyspareunia was commoner and lasted longer in patients sutured with ;Dexon' and it was also commoner in older primigravidae irrespective of the suture technique.
The professional literature on the benefits and risks of episiotomy was last reviewed critically in 1983, encompassing material published through 1980. This paper reviews the evidence accumulated since then. (Part II follows in this issue.) It is concluded that episiotomies prevent anterior perineal lacerations (which carry minimal morbidity), but fail to accomplish any of the other maternal or fetal benefits traditionally ascribed, including prevention of perineal damage and its sequelae, prevention of pelvic floor relaxation and its sequelae, and protection of the newborn from either intracranial hemorrhage or intrapartum asphyxia. In the process of affording this one small advantage, the incision substantially increases maternal blood loss, the average depth of posterior perineal injury, the risk of anal sphincter damage and its attendant long-term morbidity (at least for midline episiotomy), the risk of improper perineal wound healing, and the amount of pain in the first several postpartum days.
The concept of balanced analgesia suggests that a combination of analgesic drugs may enhance analgesia and reduce side effects after surgery. This study evaluated the effect of the combination of propacetamol (Prodafalgan) and ketoprofen (Profenid) after surgery of a herniated disc of the lumbar spine.
After randomization, 60 patients received: placebo (group 1); 2 g propacetamol (group 2); 50 mg ketoproten (group 3); or a combination of 2 g propacetamol and 50 mg ketoprofen (group 4). Drugs were administered every six hours for two days after surgery. The patients used morphine with patient controlled analgesia pumps (bolus 1 mg; lock out time 10 min) and were evaluated with a visual analogue scale (VAS) at rest and movement every six hours for two days. Side effects were noted.
The patient characteristics and surgery were identical for each of the four groups. The VAS scores throughout the study were lower in group 4 than in groups 1, 2 and 3 both at rest (P < 0.05) and on movement (P < 0.01). The cumulative dose of morphine at 48 hr was lower in group 4 than in group 1 (23.4 +/- 5 mg vs. 58.9 +/- 9 mg; P < 0.01) or group 2 (23.4 +/- 5 mg vs 43.4 +/- 6.6 mg; P < 0.05) and similar to that in group 3 (34.2 +/- 4.5 mg). The incidence of side effects was similar in all groups.
The combination of propacetamol and ketoprofen reduced pain scores both at rest and on movement. The drug combination did not reduce the morphine consumption and incidence of side effects.
To compare polyglactin 910 sutures with chromic catgut sutures for postpartum perineal repair.
A stratified randomised controlled trial, using a 2 x 2 factorial design.
The maternity unit at Ipswich Hospital NHS Trust, a district general hospital, between 1992 and 1994.
1780 women who had sustained an episiotomy or first or second degree tear following a spontaneous or simple instrumental delivery.
Policies of repair with polyglactin 910 or chromic catgut were compared. Both groups were assessed by a research midwife completing questionnaires at 24 to 48 hours and at ten days postpartum, and by self-completed questionnaires at three months after birth.
1. 24 to 48 hours postpartum: perineal pain, healing; 2. ten days postpartum: perineal pain, healing and removal of sutures; 3. three months postpartum: perineal pain, removal of sutures, resuturing, dyspareunia, and failure to resume pain-free intercourse.
Completed questionnaires were returned for 99% of women at both 24 to 48 hours and ten days and by 93% of women three months postpartum. The two groups were similar at trial entry. Significantly fewer women allocated to the polyglactin 910 reported pain in the previous 24 hours at both 24 to 48 hours (59% vs 67%; RR 0.89, 95% CI 0.83-0.95; 2P < 0.01), and ten days (24% vs 29%; RR 0.81, 95% CI 0.69-0.95; 2P = 0.01). At three months postpartum there was no clear difference between the groups in terms of perineal pain, dyspareunia or failure to resume pain-free intercourse. More women in the polyglactin 910 group reported that some suture material had been removed (12% vs 7%; RR 1.62, 95% CI 1.19-2.21; 2P < 0.01). Three women in the polyglactin 910 group had required resuturing compared with ten in the chromic catgut group (RR 0.30; 95% CI 0.08-1.09; 2P = 0.1).
Using polyglactin 910 rather than chromic catgut for perineal repair leads to about one fewer women among every 20 having perineal pain and using analgesia ten days postpartum. Its only apparent disadvantage is that more women, again estimated as 1 in 20, report having material removed during healing. Data from this and other trials suggest that for every 100 women repaired with a polyglycolic acid-based material, about one fewer will require resuturing.
To determine if diclofenac suppositories administered prophylactically produce effective and lasting analgesia following perineal injury.
A randomised double blind placebo controlled trial.
York District Hospital.
One hundred women sustaining objective perineal injury (second degree tear or episiotomy) during spontaneous vaginal delivery at term.
Suppositories were administered at the time of repair and approximately 12 hours later. The suppositories were randomised prior to issue by the pharmacy department and contained either 100 mg diclofenac or placebo.
Pain scores assessed at 12, 24, 48 and 72 hours after delivery using a six point numerical scoring system and the use of additional analgesia and local treatments to the perineum.
The mean pain score was significantly reduced in the diclofenac group at 24, 48 and 72 hours after delivery (0.86, 0.7 and 0.59, respectively) compared with the control group (1.64, 1.31 and 1.5; P < 0.005). In addition there was less supplementary analgesia required (eight women only at 72 hours compared with 15 in the control group) and this was limited to paracetamol or topical treatments to the perineum.
Prophylactic rectal diclofenac provides effective analgesia after perineal repair and its effect appears to be maintained into the second and third postpartum days.
The objective of this single-center, single-dose, double-blind randomized parallel group study was to evaluate the analgesic efficacy of a new liquid formulation of ketoprofen at two dose levels (25 mg or 50 mg) compared to a commercially available liquid form of dipyrone 500 mg and placebo with all treatments administered as drops to patients with severe postepisiotomy pain.
The study was designed with a sample size of 69 patients per treatment for a total of 276 patients. However, due to administrative changes at the site, the study was prematurely terminated; thus only 108 patients (26 to 28 patients per treatment), 18 years or older, with severe postepisiotomy pain were randomized to one of the four treatments. Treatments were assessed over a 6-hour period using standard scales for pain intensity and pain relief and a number of derived variables based on these data. Since the study medications were not identical in appearance, the preparation and administration of the study medication, and the observation of the patient, were carried out by two different individuals to maintain double-blind conditions.
All active treatments were significantly superior to placebo for several measures of analgesia including 4-hour and 6-hour SPID and TOTPAR scores. The global rating was assessed as "good" or "excellent" by over 75% of the patients in the active treatment groups compared to 7.4% of the patients in the placebo group. Reduction in pain intensity was very similar for the two-dose levels of ketoprofen and the comparator dipyrone 500 mg.
Ketoprofen 25 mg or 50 mg, and dipyrone 500 mg seem to be equally suited for use as pain relief medication after minor surgery, as well as episiotomy. This study did not demonstrate a need for more than 25 mg of ketoprofen in postepisiotomy pain. All treatments were well tolerated. No adverse events were reported.
Episiotomy is done to prevent severe perineal tears, but its routine use has been questioned. The relative effects of midline compared with midlateral episiotomy are unclear.
The objective of this review was to assess the effects of restrictive use of episiotomy compared with routine episiotomy during vaginal birth.
We searched the Cochrane Pregnancy and Childbirth Group trials register.
Randomised trials comparing restrictive use of episiotomy with routine use of episiotomy; restrictive use of mediolateral episiotomy versus routine mediolateral episiotomy; restrictive use of midline episiotomy versus routine midline episiotomy; and use of midline episiotomy versus mediolateral episiotomy.
Trial quality was assessed and data were extracted independently by two reviewers.
Six studies were included. In the routine episiotomy group, 72.7% (1752/2409) of women had episiotomies, while the rate in the restrictive episiotomy group was 27.6% (673/2441). Compared with routine use, restrictive episiotomy involved less posterior perineal trauma (relative risk 0. 88, 95% confidence interval 0.84 to 0.92), less suturing (relative risk 0.74, 95% confidence interval 0.71 to 0.77) and fewer healing complications (relative risk 0.69, 95% confidence interval 0.56 to 0.85). Restrictive episiotomy was associated with more anterior perineal trauma (relative risk 1.79, 95% 1.55 to 2.07). There was no difference in severe vaginal or perineal trauma (relative risk 1.11, 95% confidence interval 0.83 to 1.50); dyspareunia (relative risk 1.02, 95% confidence interval 0.90 to 1.16); urinary incontinence (relative risk 0.98, 95% confidence interval 0.79 to 1.20) or several pain measures. Results for restrictive versus routine mediolateral versus midline episiotomy were similar to the overall comparison.
Restrictive episiotomy policies appear to have a number of benefits compared to routine episiotomy policies. There is less posterior perineal trauma, less suturing and fewer complications, no difference for most pain measures and severe vaginal or perineal trauma, but there was an increased risk of anterior perineal trauma with restrictive episiotomy.
Background:
Patient surveys have shown that postoperative pain is often not managed well, and there is a need to assess the efficacy and safety of commonly used analgesics as newer treatments become available. Dextropropoxyphene is one example of an opioid analgesic in current use, and is widely prescribed for pain relief in combination with paracetamol under names such as Co-proxamol and Distalgesic.
Objectives:
To determine the analgesic efficacy and adverse effects of single dose oral Dextropropoxyphene alone and in combination with paracetamol (acetaminophen) for moderate to severe postoperative pain.
Search strategy:
Published reports were identified from: Medline (1966 - November 1996), Biological Abstracts (1985 - 1996), Embase (1980 - 1996), the Cochrane Library (Issue 4 1996), and the Oxford Pain Relief Database (1954 - 1994). Additional studies were identified from the reference lists of retrieved reports. Date of the most recent searches: July 1998.
Selection criteria:
The inclusion criteria used were: full journal publication, postoperative pain, postoperative oral administration, adult patients, baseline pain of moderate to severe intensity, double-blind design, and random allocation to treatment groups which included dextropropoxyphene and placebo or a combination of dextropropoxyphene plus paracetamol and placebo.
Data collection and analysis:
Data were extracted by two independent reviewers, and trials were quality scored. Summed pain intensity and pain relief data were extracted and converted into dichotomous information to yield the number of patients with at least 50% pain relief. This was used to calculate the relative benefit and number-needed-to-treat (NNT) for one patient to achieve at least 50% pain relief.
Main results:
Six trials (440 patients) compared dextropropoxyphene with placebo and five (963 patients) compared dextropropoxyphene plus paracetamol 650 mg with placebo. For a single dose of dextropropoxyphene 65 mg in postoperative pain the NNT for at least 50% pain relief was 7.7 (95% confidence interval 4.6 to 22) when compared with placebo over 4-6 hours. For the equivalent dose of dextropropoxyphene combined with paracetamol 650 mg the NNT was 4.4 (3.5 to 5.6) when compared with placebo. These results were compared with those for other analgesics obtained from equivalent systematic reviews. Pooled data showed increased incidence of central nervous system adverse effects for dextropropoxyphene plus paracetamol compared with placebo.
Reviewer's conclusions:
The combination of dextropropoxyphene 65 mg with paracetamol 650 mg shows similar efficacy to tramadol 100 mg for single dose studies in postoperative pain but with a lower incidence of adverse effects. The same dose of paracetamol combined with 60 mg codeine appears more effective but, with the slight overlap in the 95% confidence intervals, this conclusion is not robust. Adverse effects of both combinations were similar. Ibuprofen 400 mg has a lower (better) NNT than both dextropropoxyphene 65 mg plus paracetamol 650 mg and tramadol 100 mg.
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