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CTRI Number  CTRI/2026/03/105762 [Registered on: 10/03/2026] Trial Registered Prospectively
Last Modified On: 09/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Biological
Surgical/Anesthesia
Process of Care Changes 
Study Design  Other 
Public Title of Study   Methods to reduce pain and improve healing after tonsil removal surgery 
Scientific Title of Study   Clinical efficacy of platelet rich plasma and bupivacaine in pain and healing after tonsillectomy . A randomised control 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  Shivani Thakur 
Designation  Junior Resident 
Affiliation  Indira Gandhi Medical College Shimla 
Address  Post Graduate Student of Department of otorhinolaryngology - Head and neck Surgery , Indira Gandhi Medical College

Shimla
HIMACHAL PRADESH
171001
India 
Phone  8580682965  
Fax    
Email  vani00999@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jagdeep Thakur 
Designation  Professor 
Affiliation  Indira Gandhi Medical College shimla 
Address  Department of ENT Indira Gandhi Medical College Shimla

Shimla
HIMACHAL PRADESH
171001
India 
Phone  9418477400  
Fax    
Email  anujagdeep@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jagdeep Thakur 
Designation  Professor 
Affiliation  Indira Gandhi Medical College shimla 
Address  Department of ENT Indira Gandhi Medical College Shimla

Shimla
HIMACHAL PRADESH
171001
India 
Phone  9418477400  
Fax    
Email  anujagdeep@gmail.com  
 
Source of Monetary or Material Support  
Department of ENT , Indira Gandhi Medical College Shimla Himachal Pradesh  
 
Primary Sponsor  
Name  Indira Gandhi Medical College shimla HP  
Address  Indira Gandhi Medical College Lakkar Bazaar Shimla HP 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shivani Thakur  Indira Gandhi Medical College Shimla Hospital   Department Of ENT OPD,10th floor room no. 1016 Male ENT ward block E 1st floor Female ENT ward block D 3rd floor
Shimla
HIMACHAL PRADESH 
8580682965

vani00999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Indira Gandhi Medical College   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bupivacaine  Bupivacaine (0.5%) is a local anaesthetic having a short half life infiltrated to tonsillar fossa / anterior tonsillar pillar after tonsillectomy for post operative pain control. 
Intervention  Platelet rich plasma  Platelet rich plasma is a plasma fractions of patients own peripheral blood, which is infiltrated into tonsillar fossa / anterior tonsillar pillar immediately after tonsillectomy to assess effect on post operative pain and healing . 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Recurrent sore throat, As per American Academy of Otolaryngology Head and Neck
surgery;
I. seven or more well-documented clinically significant , adequately
treated sore throat in the preceding year, or
II. five or more such episodes in each year of the preceding 2 years, or
III. three or more such episodes in each of the preceding 3 years.
Patient willing to give consent to participate  
 
ExclusionCriteria 
Details  Allergic to bupivacaine
1. Current acute infection or peritonsillar abscess
2. History of palatine tonsils surgery or malignancy
3. Coagulopathy, bleeding disorder, thrombocytopenia
4. Other serious co-morbidity, anaemia, immunodeficiency, hypertensive,
Chronic Renal Failure.
5.Patients on NSAIDS, anti-coagulants, anti-hypertensive drugs. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To evaluate post operative pain after platelet rich plasma and
bupivacaine injection in tonsillar bed/anterior tonsillar pillar using Visual
analogue score (VAS).
2. To evaluate wound healing between the platelet rich plasma and bupivacaine
using a five grade scale based on percentage of slough coverage. 
Post operative Pain - Day 1 , day 3 , day 5 , Day 7
Healing - Day 1 , Day 3, Day 5 Day 7 and , Day 14
 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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 2/ Phase 3 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   The. primary aim of the study,
 To evaluate post operative pain score after platelet rich plasma and
bupivacaine injection in tonsillar bed/anterior tonsillar pillar using Visual
analogue score (VAS).
2. To evaluate wound healing between the platelet rich plasma and bupivacaine
using a five grade scale based on percentage of slough coverage.
Tonsillectomy remains one of the most frequently performed otolaryngologic operations and
post operative pain and healing remains major problems for the patients.
Pain is due to mucosal injury, muscle injury and exposed cranial nerve endings leading to
inflammation and spasm of pharyngeal musculature. After tonsillectomy high degree of
swelling within 24 hours in uvula and anterior tonsillar pillar and posterior tonsillar pillar may
hinder with healing and is associated with increased post operative complication. It can lead to
decreased oral intake, vomiting, difficulty breathing and dehydration requiring hospital re-admission.
Bupivacaine is a long acting local anaesthetic of the amino amide group. It is indicated for
infiltration anesthesia, nerve block, epidural and intrathecal anesthesia. It can also be used in
surgical area by infiltration or by local application . By blocking the afferent nerve endings
through the inhibition of voltage gated ion channels it decreases the onset of post operative
pain.
Platelet rich plasma (PRP) have been used for various indications for many years, resulting in
interest in potential autologous PRP in regenerative medicine. It is a suitable option with
clinical benefits, with positive clinical outcomes.
PRP which is also known as platelet enriched plasma, platelet rich concentrate, autologous platelet gel and platelet releasate. It is defined as part of plasma fraction of autologous peripheral blood that has a platelet
concentration above baseline. The serum contains epidermal growth factor, tumor growth
factor beta firbronectin, all of which have the property of speeding the process of
epithelisation. It also has antibacterial properties because of immunoglobulin G and lysozyme
ingredients.
The objective of the study is to evaluate the clinical efficacy of PRP and bupivacaine in
reducing postoperative pain and promoting tissue healing following tonsillectomy. By
systematically assessing pain levels and the healing process in the postoperative period, this
study aims to generate evidence that may guide future clinical practice. The results are
expected to help otolaryngologists enhance postoperative care, reduce patient discomfort, and
improve recovery outcomes in individuals undergoing tonsillectomy.
 
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