| 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
|
|
|
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
|
|
|
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. |