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CTRI Number  CTRI/2025/10/095872 [Registered on: 10/10/2025] Trial Registered Prospectively
Last Modified On: 08/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study of different intra-articular drugs in patients undergoing arthroscopic anterior cruciate ligament reconstruction for post operative pain. 
Scientific Title of Study   Post-operative pain relief with intra-articular Bupivacaine alone and in combination with aqueous Diclofenac or Dexmedetomidine in patients undergoing arthroscopic anterior cruciate ligament reconstruction 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manoj Kumar Meena 
Designation  Post Graduate Resident 
Affiliation  Maulana Azad Medical College 
Address  Department of Orthopaedics Lok Nayak Hospital
Maulana Azad Medical College New Delhi
Central
DELHI
110002
India 
Phone  9711589723  
Fax    
Email  manoj.meena547@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sumit Arora 
Designation  Professor 
Affiliation  Maulana Azad Medical College 
Address  Room No 608 Orthopaedics Block Lok Nayak Hospital
Maulana Azad Medical College New Delhi
Central
DELHI
110002
India 
Phone  9868329389  
Fax    
Email  sumitaroraortho@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Manoj Kumar Meena 
Designation  Post Graduate Resident 
Affiliation  Maulana Azad Medical College 
Address  Department of Orthopaedics Lok Nayak Hopsital
Maulana Azad Medical College New Delhi
Central
DELHI
110002
India 
Phone  9711589723  
Fax    
Email  manoj.meena547@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College, 2- Bahadur Shah Zafar Marg, New Delhi, India 110002 
 
Primary Sponsor  
Name  Maulana Azad Medical College 
Address  Department of Orthopaedics 2 - Bahadur Shah Zafar Marg New Delhi India 110002 
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 Manoj Kumar Meena  Maulana Azad Medical College  Room No 601 Department of Orthopaedics Lok Nayak Hospital New Delhi
Central
DELHI 
9711589723

manoj.meena547@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAMC Institutional committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M236||Other spontaneous disruption of ligament(s) of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  -Bupivacaine (0.25%-19mL Intra articular single dose). - Bupivacaine (0.25%-19mL Intra articular single dose + Aqueous Diclofenac (75mg -1mL Intra articular single dose ). -Bupivacaine (0.25%-19mL Intra articular single dose + Dexmedetomidine ( 100mcg-1mL Intra articular single dose)  Administration of intra-articular Bupivacaine (0.25% 19 mL)alone and in combination with aqueous Diclofenac (75mg- 1mL) or Dexmedetomidine (100mcg-1mL) intra venously single dose in patients undergoing arthroscopic anterior cruciate ligament reconstruction 
Comparator Agent  -Bupivacaine (0.25%-19mL Intra articular single dose). - Bupivacaine (0.25%-19mL Intra articular single dose + Aqueous Diclofenac (75mg-1mL Intra articular single dose ). -Bupivacaine (0.25%-19mL Intra articular single dose + Dexmedetomidine ( 100mcg-1mL Intra articular single dose).  Postoperative pain relief with administration of intra-articular Bupivacaine alone and in combination with aqueous Diclofenac or Dexmedetomidine in patients undergoing arthroscopic anterior cruciate ligament reconstruction 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients of age 18 to 50 years have an anterior cruciate ligament tears who undergoing primary arthroscopic anterior cruciate ligament reconstruction.
 
 
ExclusionCriteria 
Details  History of cardiovascular or pulmonary or hepatic or renal or neuropsychiatric or endocrine diseases or acid peptic disease or alcohol or drug addiction

Chronic pain treatment or hypertension treated with alpha methyldopa or Clonidine or beta adrenergic blockers

Pregnant women and nursing women

Body mass index more than 35 kg per metre square

Bony ACL avulsion and other ligaments or meniscus requiring surgery

History of allergy to the drugs being used in the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Pain assessment by visual analogue score (VAS) in post operative period.  Visual analogue score (VAS) at 3rd, 6th, 12th, 24th, 36th, and 48th hours post operatively. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Time duration since surgery to first dose of rescue analgesia.
2. Total post operative analgesia requirement in the first 48 hours.
3. Heart rate, Respiratory rate and Blood pressure monitoring at 3rd, 6th, 12th, 24th, 36th, and 48th hours post operatively.
4. Duration of post operative stay in hospital. 
Upto 48 hours of post operatively. 
 
Target Sample Size   Total Sample Size="39"
Sample Size from India="39" 
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)   25/10/2025 
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  

Anterior Cruciate Ligament (ACL) injury is a very common problem of the knee, especially in athletes. Anterior Cruciate Ligament injury is a functionally disabling condition, also it is a common etiology of knee instability and dysfunction, and it also predisposes the knee for early onset of degenerative changes in the knee.

The aim of the treatment is to provide a stable joint which allows one to return to preinjury level of activity, improve knee-related quality of life, and avoid the late sequelae of an anterior cruciate ligament deficient knee. Anterior Cruciate Ligament reconstruction gives predictable and good results with various objective and subjective scores.

Post-operative pain is often encountered as a major obstacle delaying hospital discharge and preventing early rehabilitation. Systemic opioid and non-opioid agents have been tried previously for pain relief. It has been observed that through intraarticular injections a number of systemic adverse effects can be avoided. The most preferred local anesthetic is Bupivacaine, which has been reported to have higher success rates. Intra-articular administration of local anesthetics provides adequate but short-term analgesia. Hence, various adjuvant agents need to be added to the local anesthetics; among which opioids are the most used.

The aim of this study will be to compare the postoperative analgesic efficacy of intra-articular injection of bupivacaine alone vs when it will be combined with aqueous diclofenac or dexmedetomidine. 
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