| CTRI Number |
CTRI/2025/08/093584 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Using a nerve block to reduce pain in children undergoing tonsil removal surgery. |
|
Scientific Title of Study
|
The efficacy and safety of palatine nerve block in reducing postoperative pain and recovery time in patients undergoing conventional tonsillectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shilpa Susan Mathew |
| Designation |
Assistant Professor |
| Affiliation |
Christian Medical College,Vellore |
| Address |
ENT Unit II Office, CMC Hospital Campus, Vellore 632004
Phone:0416 228 2798
Vellore
TAMIL NADU
632004
India |
| Phone |
8098121756 |
| Fax |
|
| Email |
shilpa.susan@cmcvellore.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Shilpa Susan Mathew |
| Designation |
Assistant Professor |
| Affiliation |
Christian Medical College,Vellore |
| Address |
ENT Unit II Office, CMC Hospital Campus, Vellore 632004
Phone:0416 228 2798
TAMIL NADU
632004
India |
| Phone |
8098121756 |
| Fax |
|
| Email |
shilpa.susan@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Shilpa Susan Mathew |
| Designation |
Assistant Professor |
| Affiliation |
Christian Medical College,Vellore |
| Address |
ENT Unit II Office, CMC Hospital Campus, Vellore 632004
Phone:0416 228 2798
TAMIL NADU
632004
India |
| Phone |
8098121756 |
| Fax |
|
| Email |
shilpa.susan@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Christian Medical College,Vellore,Tamil Nadu,India 632004 |
|
|
Primary Sponsor
|
| Name |
Christian Medical College,Vellore |
| Address |
Christian Medical College,
Vellore 632004 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shilpa Susan Mathew |
Christian Medical College |
Department of ENT, CMC hospital campus, Ida Scudder Road, Vellore-632004, Tamil Nadu
Vellore
TAMIL NADU |
8098121756
shilpa.susan@cmcvellore.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD,CMC VELLORE |
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 |
PALATINE NERVE BLOCK USING 0.2% ROPIVOCAINE |
Single dose of palatine nerve block using 0.2% Ropivocaine in children undergoing tonsillectomy for chronic tonsillitis. |
| Comparator Agent |
PALATINE NERVE BLOCK USING NORMAL SALINE |
Single dose of palatine nerve block using 0.9% Normal Saline in children undergoing tonsillectomy for chronic tonsillitis. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Children under 16 years of age undergoing tonsillectomy using the dissection and snare technique for chronic tonsillitis
|
|
| ExclusionCriteria |
| Details |
Other tonsillectomy technique
Duration of surgery more than 2 hours
All other indications for tonsillectomy other than chronic tonsillitis
Children with craniofacial abnormalities
Children with history of cleft palate repair or other palatoplasty procedures
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be the level of postoperative pain, assessed using Wong Baker Faces Pain Rating Scale at regular intervals over 24 hours post surgery. |
Assessment at 1 hour,4 hours,12 hours and 24 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes will include the time to first analgesic requirement, total analgesic consumption within 24 hours, incidence of complications, & parental satisfaction scores |
Assessment at 1 hour,4 hours,12 hours & 24 hours after surgery & 1 week after surgery |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shilpa.susan@cmcvellore.ac.in].
- For how long will this data be available start date provided 01-04-2026 and end date provided 30-04-2029?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This study will evaluate the efficacy of palatine nerve block in patients undergoing tonsillectomy. Tonsillectomy is a common surgical procedure often associated with significant postoperative pain which can delay recovery, reduce patient satisfaction and lead to complications. The palatine nerve block, targeting the greater and lesser palatine nerves, provides effective pain relief while reducing the need for systemic analgesics, minimizing side effects such as sedation and nausea and prompting early oral intake in children. The study will adopt a prospective, randomized controlled trial design. Participants will be randomized into two groups: one receiving the palatine nerve block alongside standard care and another receiving standard care alone. Pain scores using a validated visual analogue scale will be measured post operatively at 1 hour, 4 hours, 12 hours and 24 hours postoperatively. Data collection will be conducted over a 6-month period, with interim analyses to ensure safety and validity. Ethical approval and informed consent will be secured prior to study initiation. By the end of the study, we will determine whether the palatine nerve block offers a safe and superior pain control compared to standard care, providing valuable insights for optimizing perioperative pain management in tonsillectomy patients. |