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CTRI Number  CTRI/2024/09/073336 [Registered on: 04/09/2024] Trial Registered Prospectively
Last Modified On: 30/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to test how well dexamethasone and clonidine help reduce pain after knee surgery using a nerve block. 
Scientific Title of Study   Comparison of dexamethasone and clonidine with ropivacaine in adductor canal block for post-operative analgesia in elective knee arthroscopic surgeries 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr B S Siddharth 
Designation  DNB Anasthesia Resident 
Affiliation  O P Jindal Institute Of Cancer and Cardiac Research 
Address  O P Jindal Institute Of Cancer and Cardiac Research, Model Town, Hisar, Haryana
O P Jindal Institute Of Cancer and Cardiac Research, Haryana, Model Town, Hisar, Haryana
Hisar
HARYANA
125005
India 
Phone  9691254950  
Fax    
Email  b.s.sid1997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ritu Chopra 
Designation  Consultant, HOD Deoartment of Anasthesioogy 
Affiliation  O P Jindal Institute Of Cancer and Cardiac Research 
Address  O P Jindal Institute Of Cancer and Cardiac Research, Model Town, Hisar, Haryana

Hisar
HARYANA
125005
India 
Phone  9896539130  
Fax    
Email  rituchupts3@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Varuna Singal 
Designation  Consultant, Department of Anaesthesiology 
Affiliation  O P Jindal Institute Of Cancer and Cardiac Research, Haryana, Model Town, Hisar, Haryana 
Address  O P Jindal Institute Of Cancer and Cardiac Research, Model Town, Hisar, Haryana

Hisar
HARYANA
125005
India 
Phone  9896761634  
Fax    
Email  dr.varuna@gmail.com  
 
Source of Monetary or Material Support  
O P Jindal Institute Of Cancer and Cardiac Research, Haryana, Model Town, Hisar, Haryana 
 
Primary Sponsor  
Name  B S Siddharth 
Address  House no. 54, D.C. Colony, Urban Estate II, Hisar, Haryana, 125011 
Type of Sponsor  Other [Self] 
 
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 B S Siddahrth  O P Jindal Institute Of Cancer and Cardiac Research, Haryana, Model Town, Hisar  O P Jindal Institute Of Cancer and Cardiac Research, Model Town, Hisar, Haryana, 125005
Hisar
HARYANA 		 9691254950

b.s.sid1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JIMS Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S834||Sprain of collateral ligament of knee, (2) ICD-10 Condition: S835||Sprain of cruciate ligament of knee, (3) ICD-10 Condition: S833||Tear of articular cartilage of knee, current, (4) ICD-10 Condition: S832||Tear of meniscus, current injury,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Clonidine with 0.5% Ropivacaine  Clonidine 1mcg/kg as an adjuvant with 10ml of 0.5% Ropivacaine in Ultrasound Guided Adductor Canal Block for postoperative analgesia in arthroscopic knee surgeries. 
Intervention  Dexamethasone with 0.5% Ropivacaine   Dexamethasone 4mg as an adjuvant with 10ml of 0.5% Ropivacaine in Ultrasound Guided Adductor Canal Block for postoperative analgesia in arthroscopic knee surgeries. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1 Age 18 years to 70 years
2 ASA grade I and II.
3 Elective knee arthroscopic surgeries
4 Patients with valid informed consent
 
 
ExclusionCriteria 
Details  1 Patients not satisfying inclusion criteria
2 Allergy to local anaesthetics or opioids
3 Local infection, bleeding tendency due to anticoagulant therapy
4 Patient refusal for regional anaesthesia
5 Patients with comorbidities
6 Patient with a previous history of ipsilateral lower limb surgery
7 Substance abuse interfering with pain on the strength of opioids
8 Body mass index greater than 30
 
 
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 
1.To compare postoperative pain using visual analogue scale pain score at 0, 2, 6, 12 and 24 hours at rest
2.To compare the time to first rescue analgesic administration.
3.To compare total rescue analgesic requirement in 24 hours.
 		 24 hours postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
To compare functional status utilizing the TUG (Timed Up and Go) test postoperatively after 24 hours   24 hours postoperatively 
To compare the time to first rescue analgesic administration.  24 hours postoperatively 
To compare total rescue analgesic requirement in 24 hours.  24 hours postoperatively 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   10/09/2024 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [b.s.sid1997@gmail.com].

  6. For how long will this data be available start date provided 20-06-2026 and end date provided 20-08-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This randomized, double-blind, parallel-group study compares the efficacy of 0.5% ropivacaine with either dexamethasone versus clonidine as adjuvants for postoperative pain relief in ultrasound-guided adductor canal blocks in patients undergoing elective arthroscopic knee surgery. The primary objectives are to assess postoperative pain using the visual analogue scale at 0, 2, 6, 12, and 24 hours postoperatively, the time to first use of rescue analgesics, and the total rescue analgesic requirement in the first 24 hours. Secondary objectives include evaluating postoperative functional status using the Timed Up and Go test at 24 hours. This study aims to determine which adjuvant provides superior pain control and recovery.The study aims to provide insights into the comparative benefits of dexamethasone and clonidine as adjuvants to enhance the analgesic effects of ropivacaine.

 
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