ASSESSMENT OF POSTOPERATIVE ANALEGISC

EFFECT BY PREOPERATIVE INFILTRATION OF

BUPIVACAINE VS ROPIVACAINE IN THE ANTERIOR
PILLAR OF TONSILS

INVESTIGATOR : DR. J. JAGADEESH

GUIDE : DR. S. SELVAMANI
CO-GUIDE: DR. BHAGYAVARDHAN.B
 APPLICATION FOR ETHICAL COMMITTEE APPROVAL
TITLE OF THE PROJECT
Assessment of postoperative analgesic effect by preoperative infiltration
of tonsillar pillars with 2 ml of 0.2% Ropivacaine vs 2 ml of 0.25%
Bupivacaine into each tonsil in the anterior pillar at the lower pole, upper
pole and between the two using injection aspiration technique.
INTRODUCTION OF STUDY TOPIC
To get to the core of understanding postoperative pain in a post
tonsillectomy status seems to be a nightmare in the treatment protocol.
About one- third to one-half of patients undergoing surgery are not
adequately treated even in the 21st century. High quality postoperative pain
control, as well as recognizing and acknowledging the fact that good
analgesia is not only essential, but also a basic right to patient suffering
from pain to forego the process. The Meticulous use of Ropivacaine &
Bupivacaine infiltration to pillars preoperatively for assessing the post
operative pain obviation will be elucidated from this study.

RATIONALE
Acute pain encountered postoperatively evolving an significant stressor
causing neuroendocrine, immune and inflammatory changes leading to
elevated amount of tissue loss catabolism, immunosuppression and
increased myocardial oxygen demand. Proper prior psychological
preparation and interview within preoperative training can minimize these
above said changes. The rationale behind the study is to observe and
assess the postoperative analgesic effect by administrating 2 ml of 0.2%
Ropivacaine vs 2 ml of 0.2% Bupivacaine.

BACKGROUND AND STATEMENT OF PROBLEM

The pathways in which pain information is delivered to the central
system are defined by nociception. Many clinical options for analgesic
agents are indicated by a wide range of neurotransmitters and receptors
implicated in pathways of nociceptive pain. However Amide drugs like
Ropivacaine and Bupivacaine are employed here individually to two
separate and concluded the efficacy of one over other in ameliorate the
post operative pain.
REVIEW OF LITERATURE
1) In a prospective randomized controlled double blinded study by
Kostas Apostolopoulos et al[16] 2003 involving 77 patients (ages 15–
86 years, 34±4 years) programmed for tonsillectomy under local
anaesthesia in the ENT department from January 2000 to January
2002. All patients received 0.2–0.3g lidocaine spray 10%
(100mg/ml), 10mg/dose, immediately before local anaesthesia.
Equal amounts of local anaesthetic (20–30ml) were infiltrated to the
upper middle and lower poles of the tonsils and to the posterior
arch. Results of the study showed that the ropivacaine patients
took longer to reach surgical anaesthesia (mean 8.3min with SD
1.33min, versus 2.7min with SD 0.77 for the lidocaine group)
(P<0.001). The time spent in the operating theatre was shorter in the
lidocaine group (35+-8.5 min for ropivacaine versus 28+-6.84 min for
the lidocaine group) (P<0.001). The ropivacaine patients needed
postoperative intramuscular analgesics later (after 5-6 ). Twenty of the
34 ropivacaine patients needed no further i.m. analgesics compared
to the lidocaine group (15 of the 43 (x2=4.3, P<0.5). This study
shows that with ropivacaine the immediate postoperative pain is
less.
2) A prospective randomised controlled double-blinded study performed
by 60 FarukCicekci et al 2017[34] Department of Anaesthesiology,
Selcuk University, medical faculty, Konya, Turkey, to determine the
results of Levobupivacaine or levobupivacaine + adrenaline given
during tonsillectomy for postoperative discomfort and secondary to
nausea and vomiting; The amount of bleeding, the duration of first
oral diet and the consistency of oral intake, first analgesic request,
and complete sum of analgesics given till discharge of patients A
sum of 90 ASA Class 1 or 2 patients in between ages of 5 and 12
included in the study. Patient CHEOPS scores 10,30 and 60 minutes
as well as 6th, 12th, 24th hours. There was no substantial difference in
pain ratings between the L and LA medication classes. Important
reductions in CHEOPS scores were found at each time till post
operatively at 10th, 30th and the 60th minutes and 6th, 12th and
the 24th hours in two classes (p<0,001). There was no substantial
difference between groups L,LA (p=0,900) in the time-to-first
 oral diet Intake comparison. There was also no statistically
meaningful variations between groups L, LA in relation of time to
first analgesic demand and complete analgesic requirement.
There's no statistically meaningful difference among the two groups;
in relation to Postop PONV values for 10th, 30th and 60th minutes
and 6th, 12th and 24th hours. Group L and LA PONV values were
zero at 60 minutes and 6 and 24 hours. Levobupivacaine otherwise
Levobupivacaine + adrenaline penetration of the tonsillary fossa prior
to paediatric tonsillectomy did not induce any improvements in
postoperative discomfort, time to first oral ingestion, overall volume
of analgesics used.
3) In a prospective randomized controlled double blinded study
conducted by John A. Jebeles et al 1991[1] conducted in
Departments of Otorhinolaryngology, Anesthesiology, and
Biostatistics, UAB Medical center, Birmingham involving 14
consecutive ASA status I or II patients,
6-18 years of age, scheduled for tonsillectomy or tonsillectomy and
adenoidectomy were investigated in a double-blind, randomized study.
In bupivacaine group, tissues covering the amygdala were injected 5
min before incision with 0.25 per cent bupivacaine added with
epinephrine (1:200,000),2 -5 ml per tonsil. In saline category, the
tissues covering the tonsils were covered with normal saline along
with epinephrine (1:200000). Postop pain sensitivity was measured
using a visual analogue self-rating system. In the bupivacaine group,
the 2nd day after treatment the pain level was 19 ± 6 relative to 74 ±
8 in the saline group P < 0.0002 for the difference. Absolutely no
pain existed in the bupivacaine group on the 4-5th day following
surgery, but the pain score held at the 40-60 range in the saline
group. The difference between the groups at all times was highly
significant (P < 0.0003, repeated measures analysis of variance). At 4
h after surgery the pain intensity score in the bupivacaine group
was much lower than in the saline group (32 ± 11 vs. 77 + 11, P <
0.02). The disparity in swallowing pain among the bupivacaine &
saline classes is present even on 10th postop day (1 + 1 vs. 14 + 5,
P < 0.05). The difference between the groups at all times was
significant with P < 0.0001. Results suggest the pellets of
bupivacaine in tonsils reduce intensity of pain after tonsillectomy
dramatically.
4) In a prospective study conducted by Kazim Karaaslan et al[35]
conducted in Abant izzet baysal university, faculty of medicine,
Department of Anaesthesiology, Bolu, Turkey to test whether or
not addition of magnesium to levobupivacaine decreases the
postoperative analgesic demand and to explore potential protective
effects on laryngospasm. Seventy-five young children undergo
elective tonsillectomy and / or adenoidectomy surgery. The
medication was prepared as just 0.9 per cent NaCl for the first group
(GroupS, n=25), 0.25 per cent levobupivacaine 62 for second group
(Group L, n=25), and 0.25 per cent levobupivacaine plus 2 mg/kg
magnesium sulphate for third group (GroupM,n=25). Pain was
observed 15th minute, 1st, 4th, 8th, 16th and 24th hour postop. Pain
was assessed by mCHEOPS pain scale. All cheops values at
postoperative 4th, 8th and 16th hour were significantly lower in group
L and M than control group (p<0.05). Total analgesic requirement
was significantly decreased in group Land M at the end of
postoperative 24th hour compared to group S (p<0.05) Additional
analgesic drug was needed 36 times by 19 different patients in group
S, 15 times by 11 cases ingroup L, and 8 times by 8 cases in group M.
levobupivacaine alone or with addition of magnesium causes lower
mcheops values in paediatric patients after tonsillectomy
operations, and addition of magnesium to levobupivacaine
provides significant decrease in additional analgesic consumption.
5) In a prospective study conducted by S. Molliex et al[9] 1996 conducted
in Department of anaesthesiology, Hospital Bellevue, St. Etienne,
France which involves 68 straight healthy patients,. At the age of 8
to 65 years, either peritonsillar penetration with 0.25 per cent
bupivacaine as Group 1 or regular saline as Group 2 is randomly
distributed prior to incision. Group 3 had a peritonsillar area
soaked with 0.25 per cent bupivacaine after surgery, but before
anaesthesia was stopped. The global VAS pain scores for the first 24
h after surgery were lower in groups 1 and 3 (patients treated with
bupivacaine infiltration) when compared to the control patients in
group 2 (k0.05). There were no statistically significant differences
between the pain scores for groups 1 and 3 (preoperative and
postoperative peritonsillar infiltration with bupivacaine). However, pain
levels were not significantly different between the 3 groups at any
 individual times other than at 17 h, where the pain scores ingroup
3 were lower than those in group 2. The number of patients rated
pain free at sleep was: 6,8 and 8 patients in group 1 at 9 h, 13 h and
17 h, respectively;
3, 6 and 8 patients in group 2; and 4, 10 and 10 in group 3 at
respectively the same individual times. When VAS score comparisons
between the 3 groups are made for the entire day (average of
scores for day 0), the calculated statistical power of the trail
ensures that there is no risk for having neglected a pre-emptive or a
clinically important analgesic effect of local anaesthetic infiltrations.
On the second day, pain intensity assessed by VAS scores did not
differ be- tween the 3 groups either at rest (constant pain) or during
the swallowing of 50 ml of water. Indeed, the constant pain was: 2.4
(1.4-3.4); 3.1 (1.94.3) and 2 (1-3) for group 1, 2 and
3, respectively (mean and 95% CI). Pain on swallowing was: 3.4 (2.2-
4.6);
4.1 (2.3-5.9) and 4.1 (3.14.2) respectively for the same groups. The
results of this study were: 1) preincisional infiltration with bupivacaine
produces only mild and transient decrease in pain after tonsillectomy.
However, the addition of local analgesics to the regimen of
postoperative pain alleviation has a significant effect during the day of
surgery, 2) The effect of bupivacaine infiltration preincisionally.

AIM OF THE CURRENT STUDY

The aim of the study is to assess the analgesic effect of 2 ml of 0.25%
Bupivacaine over 2 ml of 0.2% Ropivacaine when infiltrated
preoperatively to the pillars and to assess the outcome of postoperative
pain management in children undergoing tonsillectomy under General
anaesthesia using VAS scoring.

OBJECTIVES
1.) To Compare the post -operative analgesic efficacy of Bupivacaine and
Ropivacaine at 15 mins, 1 hour , 4 hours , 12 hours , 16 hours and 24
hours of recovery using VAS scoring.
2.) To assess the time for rescue analgesia , number of patients
receiving rescue analgesia.
 METHODOLOGY
In this study, 23 children undergoing tonsillectomy under General
anaesthesia were included. Confirming to the inclusion and exclusion
criteria will be selected consecutively and assigned into two groups.

GROUP A : The first Group was subjected to 2 ml of 0.25%

Bupivacaine hydrochloride infiltrated into each tonsil in the anterior
pillar at the lower pole , upper pole and between the two with the use
of injection aspiration technique.

GROUP B : The Second group was subjected to 2 ml of 0.2%

Ropivacaine hydrochloride infiltrated into each tonsil in the anterior
pillar at the lower pole , upper pole and between the two with the use
of injection aspiration technique.
INCLUSION CRITERIA
All consented Paediatric patients aged between 5 – 12 years
belonging to ASA I – II planned for tonsillectomy under GA.
EXCLUSION CRITERIA
 Allergic reactions to drug used in study.
 Signs of Acute pharyngeal infection.
 Peritonsillar abscess.
 Bleeding disorders.
 Use of regular analgesic medication.
 Patient refusal.
STUDY AREA
The study will be conducted in the department of Anaesthesia at Sree Balaji
Medical College and Hospital , Bharath University , Chennai , India.

STUDY SETTINGS
Institutional study carried out among patients undergoing tonsillectomy in
Sree Balaji Medical College and Hospital.

STUDY PEROID
2 years period from May 2022 – May 2024.

STUDY DESIGN
Observational study.
SAMPLING METHODOLGY
Purposive sampling.

SAMPLE SIZE
(n1–1)S2 + (n2–1)S2
1 2
np = J n1+n2–2

39 s 36 +39s64
np = J 78

np3900
= = 7.07
J
78

2 2
a
n=2x Z

e2

= 2 x 1.96 x 7.07

= 23.04 ~ 23 in each group.

OPERATIONAL DEFINITION
Post operative tonsillar pain refers to the pain encountered by children
briefly around the first few hours of the post operative period.

Post tonsillar pain results due to various stressor reactions like

Inflammatory response , Coagulation response conventionally
transmitted through Transduction , Transmission , Perception and
Modulatory changes.
 DATA COLLECTION INSTRUMENTS
 Proforma for data collection with patient details, intraop and
post op monitoring details.

 Assessment fitness sheet.

 10 ml syringes PMO lines

 2 ml of 0.2% Ropivacaine

 2 ml of 0.25% Bupivacaine.

 Sterile water. Sterile gloves.

 Monitors : pulse oximeter, NIBP, ECG. Working suction.

 Paediatric breathing circuit.

 Appropriate size LMA, ET tubes.

 All emergency drugs.

DATA COLLECTION METHOD

The data will be initially entered into the Microsoft excel from the
customized proforma for analysis. SPSS software version 9.0 will be used
for calculating the p values. Comparison of means between the two group
will be done using ANOVA test, unpaired t test & paired t test.
Descriptive statistics will be presented in the form of numbers and
percentages. A ‘p’ value of <0.05 will be taken as statistically significant.
The final data will be presented in the form of tables and graph.

EXPECTED OUTCOME :
Expected outcome of this study is to find whether the child is able to
receive complete analgesic effect of Bupivacaine vs Ropivacaine on pre
incisional infiltration of these agents to the pillars.
 METHODOLOGY IN BRIEF

Children undergoing tonsillectomy are recruited and Divided into two groups an

Group A Bupivacaine Group B Ropivacaine

Pre operative pillar infiltration of 3 ml 0.25% Bupuivacaine, 3 ml o

To assess post operative pain at 15 mins, 1hr, 4hrs, 12 hrs, 16h

To assess the postoperative analgesic effect of Bupivacaine vs R

DATA COLLECTION METHOD

The data will be initially entered into the Microsoft excel from the
customized proforma for analysis. SPSS software version 9.0 will be used
for calculating the p values. Comparison of means between the two group
will be done using ANOVA test, unpaired t test & paired t test.
Descriptive statistics will be presented in the form of numbers and
percentages. A ‘p’ value of <0.05 will be taken as statistically significant.
The final data will be presented in the form of tables and graph

MECHANISMS TO ASSURE QUALITY OF STUDY

Not applicable

PAIN SCORES
Visual analogue Scale :(VAS)
VAS is a most common method for measuring pain and pain relief in day
to day to practice. One end of the scale will have a label of “ no pain”
and a smiling face and at the other end by a label of “severe pain”
represented by a crying depressed face. After looking into this facial
expression the observor marks the scale accordingly.
 PROFORMA
-Name : -Age: -MRD No:

-BMI:

-Address :

-Educational qualification :

-Socioeconomic status:

BASELINE VITALS :
BP -
HR -
sPo2
- RR -

TIME VAS BP (mmhg) HR(/min) sPo2( %) RESCUE

ANALGESIA
5 mins
1 hour
4 hours
12 hours
16 hours
24 hours
Complications:
1. Upper Airway Obstruction.
2. Tachycardia.
3. Deep cervical abscess.

*Does the study includes human subjects or animals?

This study does not include animals. Only human studies are involved.

*Are patients involved in this study?

Yes patients are involved in this study

*Are students subjects of study?

No students are not subjects of study.

*Is the procedure having invasive details about the biological sample:
The procedure is simple, rapid, invasive, inexpensive and easy to perform.

*Risk of procedure:
There are no observed risks.

*Will the subjects be involved in any other experiment during study?

No the subject will not be involved in any other experiment.

*Personal experience of the investigator with the proposed technique:

Nil.

*Details of informed consent in the form of consent appended (in local

language):
Yes
*Renumerations to the subject:
Nil
ROLE AND RESPONSIBILITIES OF ALL INVESTIGATORS WITH THEIR BRIEF
CURRICULUM VITAE:

INVESTIGATOR NAME ROLE CV

Dr. J. JAGADEESH INVESTIGATOR JUNIOR RESIDENT

Dr. S. SELVAMANI GUIDE PROFESSOR & HOD

Dr. BHAGYAVARDHAN. B CO GUIDE ASSISTANT PROFESSOR

(ANAESTHESIA)

*Budgets and details about funding: NIL

*Details of collaboration: NIL

*Details of commencement of project and date of completion of

project:
Jun 2022 to Jan 2024.

*Signature of Principal Investigators: Email id: jagadeesh13dec14@gmail.com,

Contact No.: 9941204180

*Date of Submission: 10.06.2022

*Signature of HOD :

*Signature of Guide:

*Signature of Co-Guide:
 INFORMED CONSENT FORM
Subject identification number for this trial
Title of the Project:
Comparative study of pre-operative infiltration of Ropivacaine and
Bupivacaine in post operative Analgesia following Paediatric
Tonsillectomy.
Name of the Principal Investigator : Dr. J. JAGADEESH, Tel. No.
9941204180.
1. I have received the information sheet on the above study and have
read and / or understood the written information.
2. I have been given the chance to discuss the study and ask questions.
3. I consent to take part in the study and I am aware that my
participation is voluntary.
4. I understand that I may withdraw at any time without this affecting
my future care.
5. I understand that the information collected about me from my
participation in this research and sections of any of my medical notes
may be looked at by responsible persons (ethics committee
members / regulatory authorities). I give access to these individuals to
have access to my records.
6. I understand I will receive a copy of the patient information sheet
and the informed consent form.

Participant’s Name Participant’s signature/ Thumb impression Date

Witness Name Witness signature/ Thumb impression Date

Investigator’s Name Investigator’s signature Date

 ஆராய்ச்சி திட்டத்தில் பங்குபெறுவதற்கான ஒப்புதல் கோரிக்கை

ஆராய்ச்சி திட்டத்தின் பெயர்:

.
டான்சில்ஸின் முன்புறத் தூணில் பியூபிவாகைன் VS ரோபிவாகைனின்
முன்கூட்டிய ஊடுருவல் மூலம் அறுவை சிகிச்சைக்குப் பின் ஏற்படும்
அனலிஜிஸ்க் விளைவை மதிப்பீடு செய்தல்

நான் _______________________ சொந்த மொழியில் ஆய்வின் விவரங்களை பற்றி

புரிந்து கொண்டேன்.

ஆய்வில் பங்கெடுத்துக் கொள்வதன் மூலம் என்னால் சாத்தியமான அபாயங்களையும்

நன்மைகளையும் அறிவேன்.
நான் எப்போது வேண்டுமானாலும் ஆய்விலிருந்து பின்வாங்க முடியும் என்பதை
புரிந்துகொள்கிறேன், அதோடு வழக்கமான மருத்துவ சிகிச்சையைப் பெறுவேன்.
இந்த ஆய்வில் பங்கெடுப்பதற்கு எனக்கு எந்த கட்டணமும் கிடைக்காது என்று
புரிந்துகொள்கிறேன்.
இந்த ஆய்வின் முடிவு எந்த மருத்துவ பத்திரிகைகளிலும் வெளியிடப்பட்டால், என்
தனிப்பட்ட அடையாளத்தை மதிப்பாய்வு செய்யாவிட்டால் நான் அதை எதிர்க்க மாட்டேன்.
இந்த ஆய்வில் பங்கெடுத்துக் கொள்வதன் மூலம் நான் என்ன செய்ய நினைக்கிறேன்
என்பதை நான் அறிவேன். இந்த ஆய்விற்கான எனது முழு ஒத்துழைப்பையும் தருவேன்
என்று நான் உறுதியளிக்கிறேன்.

பங்கேற்பாளரின் பெயர் பங்கேற்பாளரின் கையொப்பம் தேதி

/கட்டைவிரல் தோற்றம்

சாட்சியின் பெயர் சாட்சியின் கையொப்பம் தேதி

/கட்டைவிரல் தோற்றம்

ஆய்வாளரின் பெயர் ஆய்வாளரின் கையொப்பம் தேதி