| CTRI Number |
CTRI/2024/02/062790 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
06/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of post operative pain relief in tonsillectomy surgery using two different local anesthetics |
|
Scientific Title of Study
|
ASSESSMENT OF POSTOPERATIVE ANALGESIC EFFECT BY INFILTRATION OF BUPIVACAINE AND ROPIVACAINE IN THE ANTERIOR PILLARS OF TONSILS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jagadeesh J |
| Designation |
Junior Resident in Anaesthesiology |
| Affiliation |
Sree Balaji Medical College and Hospital |
| Address |
Department of Anaesthesiology
Sree Balaji Medical College and Hospital
CLC Works road chromepet
Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
9941204180 |
| Fax |
|
| Email |
jagadeesh13dec14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kala B |
| Designation |
Professor of Anaesthesiology |
| Affiliation |
Sree Balaji Medical College and Hospital |
| Address |
Sree Balaji Medical College and Hospital
No 7 CLC Works road
chromepet
chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
9444680908 |
| Fax |
|
| Email |
kalamhn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kala B |
| Designation |
Professor of Anaesthesiology |
| Affiliation |
Sree Balaji Medical College and Hospital |
| Address |
Department of Anaesthesiology
Sree Balaji Medical College and Hospital
CLC Works road chromepet
Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
9941204180 |
| Fax |
|
| Email |
kalamhn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree Balaji Medical College, No7, CLC Works road, Chrompet, Chennai-600044 |
|
|
Primary Sponsor
|
| Name |
Sree Balaji Medical College and Hospital |
| Address |
Sree Balaji Medical College and Hospital
Department of Anaesthesiology
No 7 CLC Works road
chromepet
chennai 44 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR JAGADEESH J |
Sree Balaji Medical College fourth floor Operating room complex |
Sree Balaji Medical College and Hospital
Department of Anaesthesiology
NO 7 CLC Works road
Chromepet
Chennai 44
Chennai
TAMIL NADU |
9941204180
jagadeesh13dec14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Infiltration of 0.2% Ropivacaine in Group B |
Patients posted for tonsillectomy will be taken as Group A and B
Group B children will receive 2ml of 0.2% Ropivacaine by Injection Aspiration technique in the anterior pillars of the tonsil |
| Intervention |
Infiltration of 0.25% Bupivacaine in Group A |
Prospectively for the six months duration Patients posted for tonsillectomy will be randomly taken as Group A and Group B
Group A children will receive 2ml of 0.25% Bupivacaine by Injection Aspiration technique in the anterior pillars of the tonsil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
ASA I AND II
WEIGHT MORE THAN 10KILOGRAMS |
|
| ExclusionCriteria |
| Details |
ASA III AND ABOVE
ALLERGIC REACTIONS
SIGNS OF ACUTE PHARNYGEAL INFECTIONS
PERITONSILLAR ABSCESS
PARENTS NOT WILLING
BLEEDING DISORDER
USE OF REGULAR ANALGESIC MEDICATION |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| post operative pain relief for surgical procedure tonsillectomy |
After Administration of local anesthetics postoperatively 15mins 30 mins 1 hr every 1hr upto 6hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess the requirement for rescue anlgesia |
After Administration of local anesthetic postoperatively 15mins 30 mins 1 hr every 1hr upto 6hrs |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2024 |
| Date of Study Completion (India) |
30/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published in scopus approved journal from Taylor and Francis group im May 2025 issue |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Children undergoing tonsillectomy will receive either Bupivacaine or Ropivacaine as decided by the Guide. Group A will receive 2ml of 0.25% Bupivacaine and Group B will receive 2ml of 0.2% Ropivacaine. The post-operative pain relief will be assessed by the principal investigator based on VAS scores at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours. The time of requirement of first rescue analgesia will be noted and Outcomes will be recorded for interpretation. |