| CTRI Number |
CTRI/2025/12/098759 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Pain relief methods for patients undergoing total knee arthroplasty : comparing adductor canal block and epidural analgesia. |
|
Scientific Title of Study
|
A comparative study between continuous adductor canal block versus epidural analgesia for postoperative pain management in total knee arthroplasty patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahul Ahuja |
| Designation |
Junior Resident |
| Affiliation |
Guru Gobind Singh Medical College Hospital, Faridkot |
| Address |
Department of Anesthesiology, Guru Gobind Singh Medical College Hospital, Faridkot, Punjab, India
Faridkot
PUNJAB
151203
India |
| Phone |
9888453068 |
| Fax |
|
| Email |
rahulahuja9888@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh Kumar |
| Designation |
Associate Professor |
| Affiliation |
Guru Gobind Singh Medical College Hospital, Faridkot |
| Address |
Department of Anesthesiology, Guru Gobind Singh Medical College Hospital, Faridkot, Punjab, India
Faridkot
PUNJAB
151203
India |
| Phone |
09464887097 |
| Fax |
|
| Email |
mukeshtala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh Kumar |
| Designation |
Associate Professor |
| Affiliation |
Guru Gobind Singh Medical College Hospital, Faridkot |
| Address |
Department of Anesthesiology, Guru Gobind Singh Medical College Hospital, Faridkot, Punjab, India
Faridkot
PUNJAB
151203
India |
| Phone |
09464887097 |
| Fax |
|
| Email |
mukeshtala@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Guru Gobind Singh Medical College Hospital, Faridkot, Punjab, 151203, India |
|
|
Primary Sponsor
|
| Name |
Guru Gobind Singh Medical College Hospital |
| Address |
Department of Anesthesiology, Guru Gobind Singh Medical College Hospital, Faridkot,151203, Punjab, India |
| 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 Rahul Ahuja |
Guru Gobind Singh Medical College Hospital, faridkot |
Department of Anesthesiology, Guru Gobind Singh Medical College Hospital, Faridkot, Punjab, India, Faridkot, Punjab
Faridkot
PUNJAB |
09888453068
rahulahuja9888@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee, Guru Gobind Singh Medical College |
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 |
| Intervention |
Adducor Canal Block |
Patient will receive 0.125% levobupivacaine with
fentanyl for post operative pain in patients of total knee Arthroplasty with
continuous adductor canal block for 48 hours
|
| Comparator Agent |
Epidural Analgesia |
Patient will receive 0.125% levobupivacaine with
fentanyl for post operative pain in patients of total knee Arthroplasty with
continuous epidural analgesia for 48 hours |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II patients |
|
| ExclusionCriteria |
| Details |
Subjects with history of allergy to local anaesthetics.
Pregnant or lactating females.
Infection or scarring at the site of Adductor Canal Block (ACB) /epidural
block.
Psychological disorders or linguistic difficulties that might interfere with
pain assessment.
History of bleeding disorders and coagulopathy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the analgesic efficacy of 0.125% levobupivacaine with fentanyl for
post operative pain in patients of total knee Arthroplasty with continuous
adductor canal block.
To evaluate the analgesic efficacy of 0.125% levobupivacaine with fentanyl for
post operative pain in patients of total knee Arthroplasty with continuous
epidural analgesia.
To Compare the effect of continuous adductor canal blockade and epidural
analgesia in post operative pain in total knee arthroplasty patients. |
Post Op pain monitoring of patient for every 2 hour for next 48 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the analgesic efficacy of 0.125% levobupivacaine with fentanyl for
post operative pain in patients of total knee Arthroplasty with continuous
adductor canal block.
To evaluate the analgesic efficacy of 0.125% levobupivacaine with fentanyl for
post operative pain in patients of total knee Arthroplasty with continuous
epidural analgesia.
To Compare the effect of continuous adductor canal blockade and epidural
analgesia in post operative pain in total knee arthroplasty patients. |
To do intra or hemodynamic monitoring and post operative monitoring for every patient for 48 hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3 |
Date of First Enrollment (India)
Modification(s)
|
01/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/03/2026 |
| 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 - NO
|
|
Brief Summary
|
This study compares the postoperative analgesic efficacy of continuous adductor canal block (CACB) and continuous epidural analgesia (CEA) in patients undergoing elective total knee arthroplasty under spinal anaesthesia. A total of 80 ASA I–II patients aged 40–75 years will be allocated into two groups of 40 each. Group A will receive ultrasound-guided CACB with continuous infusion of 0.125% levobupivacaine with fentanyl, while Group B will receive continuous epidural infusion of the same drug combination. Pain intensity will be assessed using the Visual Analogue Scale (VAS) at 6, 12, 24, and 48 hours. Secondary outcomes include need for rescue analgesia, total opioid consumption, range of motion, day of ambulation, patient satisfaction scores, hemodynamic stability, and any complications encountered. The study aims to evaluate whether CACB provides effective pain relief with better preservation of motor function and fewer adverse effects compared to epidural analgesia, thereby supporting improved postoperative recovery after knee arthroplasty. |