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International Journal of Otorhinolaryngology and Head and Neck Surgery | September 2020 | Vol 6 | Issue 9 Page 1638
International Journal of Otorhinolaryngology and Head and Neck Surgery
Meshram SN et al. Int J Otorhinolaryngol Head Neck Surg. 2020 Sep;6(9):1638-1641
http://www.ijorl.com
pISSN 2454-5929 | eISSN 2454-5937
Original Research Article
Effect of pre-incisional infiltration of 0.5% ropivacaine versus placebo
in post-operative pain relief among patients undergoing tonsillectomy
under general anaesthesia: a comparative study
Sushil Namdeorao Meshram1*, Ankesha Ghanshyam Walthare2,
Jayant Krishna Sonone3, Alok Kumar1
INTRODUCTION
Various tonsillectomy studies have shown the advantage
of local anaesthetic (LA) injection, perioperatively to
prevent pain stimulus.1 The reasons for using LA agents
perioperatively are both to block peripheral nociceptive
excitation after tissue damage and to prevent the
sensitization of the central nervous system. Ropivacaine
is a new long acting local anaesthetic, structurally
closely related to bupivacaine. It is the first
enantiomerically pure local anaesthetic, and exists as the
S-enantiomer.2 Ropivacaine exhibits less central
nervous system and cardiovascular toxicity than
bupivacaine in healthy volunteers.3,4 The objective of
the present study is to compare the efficacy of pre
incisional infiltration of ropivacaine vs. placebo on
ABSTRACT
Background: Pain is the most common complaint in the immediate post-tonsillectomy period. Inadequate post-
tonsillectomy pain management has many drawbacks. Ropivacaine is a new long acting local anaesthetic, structurally
closely related to bupivacaine.
Methods: It was a prospective double blinded randomized control trial on a total of 50 patients who were posted for
tonsillectomy. Randomization of each patient was done into two groups one of which had received 4 ml of 0.5%
ropivacaine hydrochloride solution and other 4 ml normal saline. Data entry and analysis was done with (SPSS IBM)
version 21.0. Both univariate and bivariate analysis done. Proportions were calculated for qualitative variables and
mean with standard deviation was done for quantitative variables. Required tests of significance such as Chi square
test and independent test were applied. Significance of p value is taken as p<0.05. Postoperative pain, first post op
oral intake, duration of post-operative hospital stay, and postoperative haemorrhage was assessed. The intensity of
postoperative pain was assessed on behavioural observational pain Scale and Wong baker faces pain rating scale.
Results: Pre-incisional infiltration of 0.5% Ropivacaine was an effective method to reduce post-operative pain in
patients undergoing tonsillectomy under GA. Effect of Ropivacaine was statistically significant (p<0.05).
Conclusions: We recommend the use of 0.5% ropivacaine pre-incisional infiltration in patients undergoing
tonsillectomy.
Keywords: Ropivacaine, Tonsillectomy, Adenotonsillectomy, BOPS
1Department of ENT, Tata Main Hospital, Jamshedpur, Jharkhand, India
2GMC Miraj, Miraj, Maharashtra, India
3GH Khamgoan, Khamgoan, Maharashtra, India
Received: 21 June 2020
Revised: 02 August 2020
Accepted: 03 August 2020
*Correspondence:
Dr. Sushil Namdeorao Meshram,
E-mail: sushilmeshram123@gmail.com
Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under
the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial
use, distribution, and reproduction in any medium, provided the original work is properly cited.
DOI: http://dx.doi.org/10.18203/issn.2454-5929.ijohns20203564
Meshram SN et al. Int J Otorhinolaryngol Head Neck Surg. 2020 Sep;6(9):1638-1641
International Journal of Otorhinolaryngology and Head and Neck Surgery | September 2020 | Vol 6 | Issue 9 Page 1639
postoperative pain relief among patients undergoing
tonsillectomy and
to find out the possibility of any
complication in relation to ropivacaine infiltration
into the peritonsillar fossa.
METHODS
The study was a prospective, double blinded randomized
controlled trial.
All patients who had attended ENT
outpatient clinic at
Tata Main Hospital, located in
Jamshedpur of Jharkhand State
of India with a history of
recurrent or chronic tonsillitis, from
July 2018 to June
2020
, included in this study, in whom 50 patients aged
5 to 18 years were planned for tonsillectomy.
The selection criteria were, age group between 5 and 18
years both sexes and patient undergoing tonsillectomy for
symptomatic tonsillar enlargement. Exclusion criteria
were, age group less than 5 years and more than 18 years,
patients known for bleeding disorders, liver and kidney
dysfunction, cardiovascular comorbid conditions making
him/her unfit for general anesthesia, patients with
histories of allergies and anaphylaxis and patients having
active infections such as quinsy, acute pharyngo-
tonsillitis.
The Wong-Baker pain scale (WBS) and
behavioural
observational pain scale (BOPS) were used to evaluate
post operative pain.
WBS is highly preferred by children
and parents for reporting pain severity.5
BOPS was used
to evaluate post operative pain. It is tool which has
been used to measure post-operative pain and it has
been shown to be a particularly useful tool in pre-
school children.
Patients received the study drug as per
randomization. Group 1-4 ml of 0.5% ropivacaine
hydrochloride group 2-4 ml of 0.9N normal saline.
Required tests of significance such as Chi square test and
independent test were applied at p<0.05.
RESULTS
Operation type
Among all 50 patients 47 (94%) patients underwent
tonsillectomy and 3 (6%) underwent adenotonsillectomy.
Tonsillectomy
Among those who underwent tonsillectomy, 24 (51.1%)
were on ropivacaine and 23 (48.9%) were on saline
treatment.
Adenotonsillectomy
Three patients underwent Adenotonsillectomy among
which 1 (33.4%) were in ropivacaine and 2 (66.6%) on
saline treatment.
Intra-operative bleeding
Eleven (22 %) cases have intraoperative episode of bleed
which required control by ligature. 6 (24%) were in
ropivacaine group and 5 (20%) were in saline group. No
Statistically significant difference observed in
intraoperative bleeding time in both groups (p>0.05).
Behavioral observational pain score
The average pain score of all patients at 2nd hour, 6th hour
and 10th hour is 2.52, 1.94 and 1.56 respectively. In
ropivacaine group the average pain score at 2nd hour post-
surgery is observed as 1.36, 1.24 at 6th hour and 1.08 at
10th hour. In saline group the average scores are found to
be 3.68, 2.64, 2.04 at 2nd, 6th and 10th hour respectively.
Statistically significant difference is observed in pain
scores between both groups at all time intervals (p<0.05)
(Table 1).
Table 1: Behavioural observational pain score.
BOPS
2nd hour
6th hour
10th hour
All patients
2.52
1.94
1.56
Ropivacaine
1.36
1.24
1.08
Saline
3.68
2.64
2.04
Wong Baker faces pain scores
The WB pain score is observed as 5.52, 4.28 and 3.12 at
2nd, 6th and 10th hour in all patients respectively. In
ropivacaine group pain is observed to be 3.76 after 2hrs,
3.2 after 6 hrs and 2.64 after 10 hours of operation. In
saline group pain score is found to be 7.28, 5.36 and 3.6
after 2hrs, 6 hrs and 10 hrs. of operation respectively.
Statistically significant difference is observed in WB pain
score across ropivacaine and saline groups (p<0.05)
(Table 2).
Table 2: Wong Baker faces pain scores.
Wong Baker
pain scores
2nd hour
6th hour
10th hour
All patients
5.52
4.28
3.12
Ropivacaine
3.76
3.2
2.64
Saline
7.28
5.36
3.6
Oral intake
In present study 62% started oral intake at 6 hours’ post-
surgery and 80% started at 8 hours after surgery. In
ropivacaine group 80% started oral intake after 6 hours
and 96% started after 8 hours of surgery. Whereas 44%
started oral intake in saline group at 6 hours and 64% at 8
hours after surgery. A statistically significant difference
is found between both groups (p<0.05) (Table 3).
Meshram SN et al. Int J Otorhinolaryngol Head Neck Surg. 2020 Sep;6(9):1638-1641
International Journal of Otorhinolaryngology and Head and Neck Surgery | September 2020 | Vol 6 | Issue 9 Page 1640
Table 3: Oral Intake.
Oral Intake
6 hours
8 hours
N (%)
N (%)
Ropivacaine
16 (80)
24 (96)
Saline
11 (44)
16 (64)
Post-operative admission days
It is observed that average time of admission post
operation is 3.78 days. In ropivacaine group the average
time postoperative admission is 3.44 days and in saline
group it is found to be 4.12 days. There is a statistically
significant difference between duration of admission in
saline and ropivacaine group (p<0.05) (Table 4).
Table 4: Total admission days.
Total admission days
Average
All patients
3.78
Ropivacaine
3.44
Saline
4.12
DISCUSSION
Despite advances in anaesthetic and surgical techniques,
post tonsillectomy morbidity remains a major clinical
problem. Hence studies are being performed to find
treatments with fewer side effects, especially for
paediatric patients who are more sensitive to pain. In a
study by Arikan et al, it was found that the constant
postoperative pain in the ropivacaine side at rest was
significantly less than in the placebo side on days 1, 2, 5,
and 6 (p<0.05). The post-tonsillectomy pain experienced
in the ropivacaine side when swallowing was
significantly less than that in the placebo side throughout
the study period except on day 10 (p<0.05) and
concluded that pre incisional infiltration of ropivacaine
2% appears to be effective against both early and late
postoperative pain, especially on swallowing, following
tonsillectomy in adults.6 In a prospective study of day
surgery care unit for children and a neurosurgical
postoperative care unit, 76 chilthe study was divided into
interrater reliability, concurrent validity, and construct
validity and observed that interrater reliabilities of the
observers were very good with a high agreement between
the different nurses' BOPS scores and concluded that with
BOPS, the caretaker can evaluate and
document pain with high reliability and validity and
thereby improve postoperative pain treatment in
children.7 In a study by Helgadóttir on 68 children
undergoing tonsillectomy were taught to use the Wong-
Baker faces pain rating scale.8 The WB pain score was
observed as 5.52, 4.28 and 3.12 at 2nd, 6th and 10th hour in
All patients respectively. In ropivacaine group pain was
observed to be 3.76 after 2 hrs, 3.2 after 6 hrs and 2.64
after 10 hours of operation. In saline group pain score is
found to be 7.28, 5.36 and 3.6 after 2 hrs, 6 hrs and 10 hrs
of operation respectively. Statistically significant
difference is observed in WB pain score across
ropivacaine and saline groups (p<0.05). Akoglu et al
compared the effects of ropivacaine and bupivacaine on
post-tonsillectomy pain in children and found that
local ropiva-caine infiltration is a safe and effective
method and equivalent to bupivacaine for post-
tonsillectomy pain. In their study it was found that the
pain scores were similar between the bupivacaine
and ropivacaine groups (p>0.05). The pain scores in both
analgesia groups were significantly (p<0.05) lower 1, 4,
12, 16, and 24h post-operatively compared to the control
group. Analgesic requirements and the time to first
analgesia were also significantly (p<0.05) different
between the analgesia and control groups.1
In present study 62% started oral intake at 6 hours’ post-
surgery and 80% started at 8 hours after surgery. In
ropivacaine group 80% started oral intake after 6 hours
and 96% started after 8hours of surgery. Whereas 44%
started oral intake in saline group at 6 hours and 64% at 8
hours.
In a study of 120 patients aged between 4 and 13 years,
who were randomized into four groups. In group 1 (31
patients, mean age (8.40±4.05 years) received topical
lidocaine hydrochloride with 1:100,000 epinephrine was
applied to surgical bed following tonsillectomy. Group 2
(29 patients, mean age (8.15±4.20 years)) and group (31
patients, mean age (7.75±3.95 years)) were administered
0.25% bupivacaine hydrochloride with 1:200,000
epinephrine and 0.5% ropivacaine respectively. In Group
4 (29 patients, mean age 8.15±4.20 years) topical 0.9%
saline was used. The difference between mean operative
time of the three groups against saline injected group was
statistically significant (p<0.001) in their study. The
difference between mean pain score between ropivacaine
and bupivacaine groups was not statistically significant
(p>0.001), they concluded that ropivacaine infiltration is
as effective as bupivacaine for post-tonsillectomy pain
management in children.9 In a study by Oghan et al, to
determine whether post-operative administration of
topical ropivacaine hydrochloride decreases morbidity
following Adenotonsillectomy it was found that in first
hour there was no significant pain-relieving effect seen in
the ropivacaine group (p>0.05).10 The other hours and
days there were statistically significance between the two
groups (p<0.001). Also, the other post-operative
parameters such as nausea, fever, vomiting, odour,
bleeding, otalgia and trismus were not statistically
different between the two groups. They concluded that
locally 1.0% ropivacaine administration significantly
relieves the pain of paediatric tonsillectomy and, it is a
safe and effective method. Also, high concentrations of
ropivacaine may produce clinically significant pain relief.
CONCLUSION
With our study, we conclude that pre-incisional
infiltration of 0.5 % ropivacaine is an effective method to
reduce post-operative pain in patients undergoing
tonsillectomy under GA. It is also effective for early start
Meshram SN et al. Int J Otorhinolaryngol Head Neck Surg. 2020 Sep;6(9):1638-1641
International Journal of Otorhinolaryngology and Head and Neck Surgery | September 2020 | Vol 6 | Issue 9 Page 1641
of postoperative oral feed and also reduces the cost of
postoperative hospital stay. There were no additional
complication raised because of ropivacaine use and we
recommend routine use of 0.5% ropivacaine as pre-
incisional infiltration in patients undergoing tonsil-
lectomy.
Funding: No funding sources
Conflict of interest: None declared
Ethical approval: The study was approved by the
Institutional Ethics Committee
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Cite this article as: Meshram SN, Walthare AG,
Sonone JK, Kumar A. Effect of pre-incisional
infiltration of 0.5% ropivacaine versus placebo in
post-operative pain relief among patients undergoing
tonsillectomy under general anaesthesia: a
comparative study. Int J Otorhinolaryngol Head Neck
Surg 2020;6:1638-41.
