| CTRI Number |
CTRI/2026/03/105839 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study on the effect of giving pain relief injection before surgery versus after surgery around the tonsil area in children undergoing coblation tonsil removal using ropivacaine medicine. |
|
Scientific Title of Study
|
A comparative study on the effect of pre incisional versus postoperative peritonsillar infiltration of 0 point 75 percentage ropivacaine among paediatric patients undergoing coblation 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 |
Bhagyashree Padickal |
| Designation |
Post Graduate Student |
| Affiliation |
Al Azhar Medical Collage and Super Speciality Hospital |
| Address |
Al Azhar Medical Collage and Super Speciality Hospital,
Ezhalloor (po),
Idukki,Kerala
685605
Thazhumon Padickal,
Edathitta (po),
Pathanamthitta, Kerala
691555
Idukki
KERALA
685605
India |
| Phone |
09745443618 |
| Fax |
|
| Email |
bhagyashreepadickal5887@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Davis Thomas Pulimoottil |
| Designation |
Professor |
| Affiliation |
Al Azhar Medical Collage and Super Speciality Hospital |
| Address |
Al Azhar Medical Collage and Super Speciality Hospital,
Ezhalloor (po)
Idukki,Kerala
685605
Pulimoottil House,
Madathiparambu Road,
Vennala (po),
Kochi, Kerala
682028
Idukki
KERALA
685605
India |
| Phone |
7639285181 |
| Fax |
|
| Email |
davisthomasp@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Davis Thomas Pulimoottil |
| Designation |
Professor |
| Affiliation |
Al Azhar Medical Collage and Super Speciality Hospital |
| Address |
Al Azhar Medical Collage and Super Speciality Hospital,
Ezhalloor (po)
Idukki,Kerala
685605
Pulimoottil House,
Madathiparambu Road,
Vennala (po),
Kochi, Kerala
682028
Idukki
KERALA
685605
India |
| Phone |
7639285181 |
| Fax |
|
| Email |
davisthomasp@yahoo.in |
|
|
Source of Monetary or Material Support
|
| AL AZHAR MEDICAL COLLEGE AND SUPER SPECIALITY HOSPITAL,EZHALLOOR,THODUPUZHA, KERALA, INDIA
Pin: 685608 |
|
|
Primary Sponsor
|
| Name |
Bhagyashree Padickal |
| Address |
Al Azhar Medical Collage and Super Speciality Hospital, Ezhalloor (po), Idukki,Kerala, India
685605
|
| 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 |
| Dr Davis Thomas Pulimoottil |
Al Azhar Medical College and Super Speciality Hospital |
Department of Otorhinolaryngology
Idukki
KERALA |
7639285181
davisthomasp@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
Infiltration of 0 point 75 percentage ropivacaine
|
Intervention Group is Group A Participants will receive pre incisional peritonsillar infiltration of 0 point 75 percentage ropivacaine at a dose of 0 point 2 milliliter per kilogram full stop The infiltration will be administered bilaterally after induction of general anesthesia but before the start of the coblation tonsillectomy procedure full stop Comparator Group is Group B the participants will receive post operative peritonsillar infiltration of 0 point 75 percentage of ropivacaine at a dose of 0 point 2 milligram per kilogram full stop The infiltration will be administered into the bilateral anterior and posterior pillars and superior poles of the tonsillar fossae only after the tonsils are excised and hemostasis is achieved full stop Both groups will undergo a standardized coblation tonsillectomy technique and a uniform general anesthesia protocol including intraoperative multimodal analgesia bracket Paracetamol 15 milligram per kilogram coma Fentanyl 2 microgram per kilogram coma Dexamethasone 0 point 1 milligram per kilogram and Morphine 0 point 05 milligram per kilogram bracket full stop |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Patients with a diagnosis of Chronic tonsilitis fulfilling the Paradise guideline |
|
| ExclusionCriteria |
| Details |
Procedure other than Tonsillectomy
Peritonsillar abscess
Bleeding disorders
Allergy to Ropivacaine |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 The outcomes to be measured Pain scoring will be done using the FACES pain scale scale at 4 coma 6 coma 24 hours post operative and day 7 of post operative day
2 The time at which patients could tolerate
oral feeds will also be documented
3 Parental satisfaction regarding the pain outcomes will also be noted |
4 coma 6 coma 24 hours post operative and day 7 of post operative day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 aims to compare the effect of pre incisional verses post operative peritonsillar infiltration of 0 point 7 percent ropivacaine on post tonsillectomy pain in pediatric patients undergoing coblation tonsillectomy full stop post operative pain is a major cause of morbidity following tonsillectomy in children and may delay oral intake and recovery full stop Although local infiltration analgesia has been used to reduce pain limited evidence exists regarding the optimal timing of ropivacaine infiltration especially in coblation tonsillectomy full stop This prospective study will include children aged 3 to 17 years diagnosed with chronic tonsillitis and planned for coblation tonsillectomy full stop Participants will be randomized into two groups full stop Group A will receive preincisonal peritonsillar infiltration of 0 point 75 percent ropivacaine at a dose of 0 point 2 milgram per kilogram full stop Group B will receive post operative infiltration of the same dose full stop Post operative pain will be assessed using Wong Baker FACES pain scale at 4 hours coma 6 hours coma 24 hours and on the seventh post operative day full stop Time to initiation of oral intake and parental satisfaction will also be recorded full stop The study aims to determine whether the timing of ropivacaine infiltration provides better postoperative pain relief and facilitates early recovery in children undergoing coblation tonsillectomy full stop |