| CTRI Number |
CTRI/2026/01/100451 [Registered on: 07/01/2026] Trial Registered Prospectively |
| Last Modified On: |
06/01/2026 |
| 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
|
TWO BLOCKS COMPARISION FOR ANALGESIA IN TOTAL KNEE REPLACEMENT. |
|
Scientific Title of Study
|
A Tale of Two Blocks: Comparing Adductor Canal and Dual Subsartorial
techniques in Total Knee Replacement. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MANISH CHOUBEY |
| Designation |
PRIMARY DNB RESIDENT |
| Affiliation |
MMI NARAYANA SUPERSPECIALITY HOSPITAL,RAIPUR |
| Address |
MMI Narayana Hospital, Raipur, Dhamtari Road, Lalpur,
Raipur, Chhattisgarh 492001
Raipur
CHHATTISGARH
492001
India |
| Phone |
8447093897 |
| Fax |
|
| Email |
manishchb20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arun Andappan |
| Designation |
Consultant |
| Affiliation |
MMI NARAYANA SUPERSPECIALITY HOSPITAL,RAIPUR |
| Address |
MMI Narayana Hospital, Raipur, Dhamtari Road, Lalpur,
Raipur, Chhattisgarh 492001
Raipur
CHHATTISGARH
492001
India |
| Phone |
9584411011 |
| Fax |
|
| Email |
arunandappan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MANISH CHOUBEY |
| Designation |
PRIMARY DNB RESIDENT |
| Affiliation |
MMI NARAYANA SUPERSPECIALITY HOSPITAL,RAIPUR |
| Address |
MMI Narayana Hospital, Raipur, Dhamtari Road, Lalpur,
Raipur, Chhattisgarh 492001
Raipur
CHHATTISGARH
492001
India |
| Phone |
8447093897 |
| Fax |
|
| Email |
manishchb20@gmail.com |
|
|
Source of Monetary or Material Support
|
| MMI NARAYANA SUPERSPECIALITY HOSPITAL , RAIPUR |
|
|
Primary Sponsor
|
| Name |
MMI NARAYANA SUPERSPECIALITY HOSPITAL , RAIPUR |
| Address |
MMI Narayana Hospital, Raipur, Dhamtari Road, Lalpur, Raipur, Chhattisgarh 492001 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 MANISH CHOUBEY |
MMI NARAYANA SUPERSPECIALITY HOSPITAL , RAIPUR |
Operation Theatre,OT-3 ,second floor,MMI Narayana Hospital, Raipur, Dhamtari Road, Lalpur, Raipur, Chhattisgarh 492001
Raipur
CHHATTISGARH |
8447093897
manishchb20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE-AIIMS,RAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ADDUCTOR CANAL BLOCK |
ADDUCTOR CANAL BLOCK IN TOTAL KNEE REPLACEMNENT AS A COMPARATOR GIVEN ONLY 20ML OF DRUG VOLUME IN A SINGLE ADMNINSTRATION UNDER VASOADDUCTOR MEMBRANE CONFIRMING WITH DOUBLE BUBBLE SIGN. |
| Intervention |
DUAL SUBSARTORIAL BLOCK |
DUAL SUBSARTORIAL BLOCK IN TOTAL KNEE REPLACEMENT IN UNILATERAL KNEE WITH DRUG FORMULATION AS 35ml OF TOTAL DRUG VOLUME WAS PREPARED WITH A CONCENTRATION OF 0.25% Inj Bupivacaine (0.5% Bupivacaine 17.5 ml + sterile water 17.5 ml) INSERTED AT DISTAL FEMORAL TRIANGLE 15ML OF TOTAL VOLUME IN ONE LIMB IN FASCIAL PLANE IN A SINGLE ADMNISTRATION AND REST 20ML IS INJECTED NEXT TO FEMORAL ARTERY UNDER VASOADDUCTOR MEMBRANE AFTER NEGATIVE ASPIRIATION |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age 18-75 years of ASA I and II Physical Classes, posted for
Total Knee Replacement. |
|
| ExclusionCriteria |
| Details |
Age less than 18 and more than 75, ASA III and IV, Infection at injection
site, Pregnancy, lactating mother, Patient with psychological, neurological or coagulation
disorder, History of allergy to local anaesthetics or drugs used in the study. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
PRIMARY OBJECTIVE:
1) Duration of post-operative analgesia.
2) Total dose of rescue analgesic required in first 24 hours.
3) VAS (Visual Analog Scale) score at 2, 4, 6, 12 and 24 hours post-operatively.
4) Motor performance and Range of movement in the knee joint in post operative period.
|
*RESCUE ANALGESIA IN FIRST 24HOURS
* VAS (Visual Analog Scale) score for pain at 2, 4, 6, 12 and 24 hours post-operatively.
*Motor performance and Range of movement in the knee joit--WITHIN 24 HOURS. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SECONDARY OBJECTIVE:
1) To analyse the incidences of complications, if any, associated with Adductor Canal Block, Dual Subsartorial Block & Pre Anesthesia Checkup
2) To assess the side effects of drugs used in the study |
Both the outcomes at 5 minutes 10 minutes 15 minutes 30 minutes 60 minutes & 120 minutes minutes regularly after the intervention done. |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/01/2026 |
| 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="2"
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
|
A Tale of Two Blocks: Comparing
Adductor Canal and Dual Subsartorial Techniques in Total Knee Replacement will
be a prospective randomized controlled trial to evaluate postoperative
analgesia and motor performance in patients undergoing total knee replacement
(TKR), which often causes significant pain impeding mobility and recovery.
Peripheral nerve blocks like Adductor Canal Block (ACB) and Dual Subsartorial
Block (DSB) provide targeted relief while preserving motor function, and this
study will compare their efficacy. The primary aim will be to assess
differences in analgesia and motor function, with objectives measuring
analgesia duration, total rescue analgesic dose in the first 24 hours, VAS
scores at 2, 4, 6, 12, and 24 hours postoperatively, and motor performance with
knee range of motion. Secondary objectives will analyze complications from ACB,
DSB, and post-anesthesia care, plus drug side effects.
The study will be conducted at MMI
Narayana Multi-Speciality Hospital in Raipur, Chhattisgarh, over 24 months
post-IEC and CTRI approval, including ASA I-II patients aged 18-75 scheduled
for TKR, excluding those under 18 or over 75, ASA III-IV, with infections,
pregnancy, lactation, psychological/neurological/coagulation issues, or drug
allergies. Preoperative tests will include CBC, PT/INR, blood sugar,
electrolytes, ECG, chest X-ray, and liver/kidney function. After informed
consent, patients will be randomized into ACB or DSB groups, premedicated with
pantoprazole 40 mg and alprazolam 0.25 mg nightly, receiving subarachnoid block
with 3.4 ml 0.5% hyperbaric bupivacaine. Postoperative ultrasound-guided blocks
will use 35 ml 0.25% bupivacaine (17.5 ml 0.5% bupivacaine + 17.5 ml sterile
water), monitoring vitals, VAS, motor function, and complications for 24 hours
with rescue analgesia as needed.
Sample size will be 60 (30/group),
calculated at 99% CI and power from prior data (DSB analgesia: 6.155±0.898 vs.
4.833±0.791), adding 10 for attrition. Data in MS Excel will be analyzed via
SPSS 21.0 using t-tests/Mann-Whitney U for continuous variables,
Chi-square/Fisher exact for categorical, with p<0.05 significant. |