| CTRI Number |
CTRI/2026/03/107044 [Registered on: 30/03/2026] Trial Registered Prospectively |
| Last Modified On: |
29/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two local anaesthetics (ropivacaine and bupivacaine) for pain relief after keyhole knee surgery using a nerve block technique |
|
Scientific Title of Study
|
Comparison of postoperative analgesia by ropivacaine and bupivacaine for ultrasound-guided adductor canal block in arthroscopic knee surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rakshit Singh |
| Designation |
Post Graduate student |
| Affiliation |
ABVIMS and Dr. Ram Manohar Lohia Hospital, New Delhi |
| Address |
Room no.302,third floor, Department of Anaesthesia,
ABVIMS and Dr.RML hospital
New Delhi-110001
Delhi
New Delhi DELHI 110093 India |
| Phone |
8826808052 |
| Fax |
|
| Email |
rakshitpunia6598@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Neha Gupta |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr. Ram Manohar Lohia Hospital, New Delhi |
| Address |
Room no. 302 3rd floor Department Of Anaesthesia ABVIMS and Dr. RML Hospital
New Delhi DELHI 110001 India |
| Phone |
9899567234 |
| Fax |
|
| Email |
nehaguptadeuri@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Neha Gupta |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr. Ram Manohar Lohia Hospital, New Delhi |
| Address |
Room no. 302 3rd floor Department Of Anaesthesia ABVIMS and Dr. RML Hospital
New Delhi DELHI 110001 India |
| Phone |
9899567234 |
| Fax |
|
| Email |
nehaguptadeuri@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr. Ram Manohar Lohia Hospital, Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi 110001 New Delhi |
|
|
Primary Sponsor
|
| Name |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital |
| Address |
Department of Anaesthesia ABVIMS and Dr. RML Hospital New Delhi 110001 |
| 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 Rakshit Singh |
ABVIMS and Dr RML Hospital |
Room no 302, Third Floor,Department of Anaesthesia, ABVIMS and Dr RML Hospital, New Delhi, Delhi, India-110001 New Delhi DELHI |
8826808052
rakshitpunia6598@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ABVIMS and Dr RML Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ultrasound-guided Adductor Canal Block |
single injection of local anaesthetic into the adductor canal under ultrasound guidance for postoperative pain relief after arthroscopic knee surgery |
| Intervention |
Ultrasound-guided Adductor Canal Block with Bupivacaine |
Single injection of 20 ml of 0.25% Bupivacaine in Adductor canal under ultrasound-guidance |
| Intervention |
Ultrasound-guided Adductor Canal Block with Ropivacaine |
Single injection of 20 ml of 0.25% Ropivacaine in Adductor canal under ultrasound guidance |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status 1 or 2, scheduled for elective arthroscopic knee surgery under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients on chronic analgesic therapy
Coagulopathy
Infection at block site
Allergy to local anaesthetics
Polytrauma patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of postoperative analgesia i.e. time at which first rescue analgesic required i.e. when NRS at rest is more than 4 |
0,1,3,6,12,18 and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total Dose of Rescue Analgesic required in first 24 hours |
24 hours |
| Quadriceps muscle strength using MMT Score |
0,1,3,6,12,18 and 24 hours |
| Adverse effects like local site hematoma and hemodynamic variations |
0,1,3,6,12,18 and 24 hours |
|
|
Target Sample Size
|
Total Sample Size="72" Sample Size from India="72"
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)
|
10/04/2026 |
| 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="3" Days="7" |
|
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 is a comparative interventional study to evaluate and compare the postoperative analgesia by ropivacaine and bupivacaine for ultrasound-guided adductor canal block in arthroscopic knee surgery. After obtaining Institutional Ethics Committee approval and written informed consent from patients, all patients meeting inclusion criteria will be enrolled in the study. For adductor canal block, patient will be placed in supine position with knee slightly flexed on the side of surgery. A high frequency linear ultrasound transducer will be placed on the medial surface in midline of the thigh in the transverse plane. After visualisation of the pulsatile superficial femoral artery dorsal to the sartorial muscle, probe will be moved distally and saphenous nerve will be visualised as a hyperechoic structure anterolateral to the artery in subsartorial region. Using the in-plane technique, injection site will be confirmed with an injection of 5 ml of saline, and then 20 ml of 0.25% ropivacaine or 20 ml of 0.25% bupivacaine will be injected in Group R and Group B respectively. After performing the block, hemodynamic parameters will be monitored and patient will be assessed for any adverse effects like local hematoma or any hemodynamic variations. In PACU, patient will be assessed at arrival and thereafter at 1, 3, 6 ,12, 18 and 24 hours for pain using Numerical Rating Scale(NRS) at rest and on movement. Injection tramadol 50 mg intravenous will be given as rescue analgesia when NRS at rest > 4. Time of requirement of first rescue analgesia and total dose of tramadol required in first 24 hours will be noted. Quadriceps muscle strength will be assessed using MMT Score(Manual Muscle Testing Score). |