| CTRI Number |
CTRI/2025/03/081861 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Ropivacaine injection in controlling bleeding during tonsillectomy surgery |
|
Scientific Title of Study
|
Efficacy Of Ropivacaine As A Local Infiltrative Drug On Tonsillectomy
Haemorrhage- A Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sulekha Naresh |
| Designation |
M.S. ENT Postgraduate |
| Affiliation |
Post graduate |
| Address |
SRM medical college hospital and research centre, Department of ENT, Potheri, Kattankulathur, chengalpattu
Chennai
TAMIL NADU
603203
India |
| Phone |
8056048496 |
| Fax |
|
| Email |
zulunaresh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
M. Sivaranjani |
| Designation |
M.S. ENT |
| Affiliation |
Associate professor |
| Address |
SRM medical college hospital and research centre, Department of ENT, Potheri, Kattankulathur, Chengalpattu
Chennai
TAMIL NADU
603203
India |
| Phone |
8056048496 |
| Fax |
|
| Email |
sivaranjani57@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sulekha Naresh |
| Designation |
M.S. ENT Postgraduate |
| Affiliation |
Post graduate |
| Address |
SRM medical college hospital and research centre, Department of ENT, Potheri, Kattankulathur, chengalpattu
Chennai
TAMIL NADU
603203
India |
| Phone |
8056048496 |
| Fax |
|
| Email |
zulunaresh@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM medical college hospital and research centre, Potheri, kattankulathur, chengalpattu district, Tamil Nadu, India, 603 203 |
|
|
Primary Sponsor
|
| Name |
Sulekha Naresh |
| Address |
SRM medical college hospital and research centre, Potheri, Kattankalathur, Chengalpattu, Tamil Nadu, 603203 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Sulekha Naresh |
SRM medical college hospital and research centre |
Department of ENT, Potheri, Kattankalathur, 603 203
Chennai
TAMIL NADU |
8056048496
zulunaresh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee- students, SRM medical college hospital and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J351||Hypertrophy of tonsils, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ropivacaine infiltration- given |
Local infiltration with 0.5% Ropivacaine will be given in peritonsillar space during tonsillectomy. |
| Comparator Agent |
Ropivacaine infiltration- not given |
Local infiltration with 0.5% Ropivacaine will not be given in peritonsillar space during tonsillectomy |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients who offered informed written consent/ parental informed written consent to undergo procedure.
Patients between the age group of 5 to 30 years
Patients with chronic tonsillitis with or without adenoid hypertrophy |
|
| ExclusionCriteria |
| Details |
Patients with acute pharyngeal infection
Patients with anemia, systemic hypertension
Patients with associated cardiac, hepatic, or haematological diseases.
Patients with history of hypersensitivity to amide group of anaesthetic drugs |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Intra-operative bleed
2. Post tonsillectomy haemorrhage |
1. Baseline
2. 24 hours, 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative analgesia |
6 hours, 24 hours, 48 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
06/03/2025 |
| Date of Study Completion (India) |
15/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized controlled trial, single blinded, studying the efficacy of Ropivacaine as local infiltrative drug on tonsillectomy haemorrhage. The study will be done for 18 months and all participants undergoing tonsillectomy will be included and randomised into two groups- Group A and Group B. In Group A, Ropivacaine will be given and in Group B, it will not be used. Outcomes such as intra-operative bleed, post operative haemorrhage, post operative analgesia will be assessed. |