| CTRI Number |
CTRI/2025/07/091612 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| 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
|
A Randomized control study to evaluate the efficacy of of Dual Sub sartorial block in managing post operative pain for total knee arthroplasty |
|
Scientific Title of Study
|
A Randomized control study to evaluate the efficacy of Dual Sub-sartorial Block in managing post operative pain in patients undergoing unilateral 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 |
Tejaswini |
| Designation |
Resident |
| Affiliation |
MANIPAL HOSPITAL OLD AIRPORT ROAD |
| Address |
Department of Anesthesia.
Orthopedics OT Complex.
98, HAL Old Airport Rd, Kodihalli, Bengaluru, Karnataka 560017
Bangalore
KARNATAKA
560017
India |
| Phone |
08747954969 |
| Fax |
|
| Email |
utej96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Niranjan Jayasheela |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
MANIPAL HOSPITAL OLD AIRPORT ROAD |
| Address |
Department of Anaesthesia
98, HAL Old Airport Rd, Kodihalli, Bengaluru, Karnataka 560017
Bangalore
KARNATAKA
560017
India |
| Phone |
9980758404 |
| Fax |
|
| Email |
drniruj@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tejaswini |
| Designation |
Resident |
| Affiliation |
MANIPAL HOSPITAL OLD AIRPORT ROAD |
| Address |
Department of Anesthesia.
98, HAL Old Airport Rd, Kodihalli, Bengaluru, Karnataka 560017
Bangalore
KARNATAKA
560017
India |
| Phone |
08747954969 |
| Fax |
|
| Email |
utej96@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manipal hospitals |
| Address |
Manipal Hospitals, HAL Old airport road, Kodihalli, Bangalore 560017 |
| 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 Tejaswini |
Manipal Hospitals. |
Department of Anesthesia.
Manipal Hospitals. Old airport Rood Kodihalli, Bangalore. 560017
Bangalore
KARNATAKA |
8747954969
utej96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Manipal Hospitals, Bangalore. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
USG guided nerve blocks |
USG guided adductor canal block in patients under going unilateral TKR in the immediate post operative period. (within 15-30 minutes)
Follow up at 6 hours, 12 hours and 24 hours. |
| Intervention |
USG guided nerve blocks |
USG guided nerve dual sub sartorial block in patients undergoing unilateral total knee replacement in the immediate post operative period. (within 15-30 minutes)
Follow up at 6 hours, 12 hours and 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA II/III
2. Patients undergoing unilateral total knee replacement
3. Anesthetic management plan of sub arachnoid block |
|
| ExclusionCriteria |
| Details |
1. Patient refusal to participate in the study
2. Patient allergic to the Local anesthetic used in the study
3. ASA IV patients
4. Patients undergoing bilateral TKR
5. Anesthetic management plan of General anesthesia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To understand the analgesic efficacy of dual sub sartorial block by evaluating the post operative pain score (NRS) and Patient controlled analgesia demands in 2 groups of patients (Adductor canal block and dual sub sartorial block) in patients undergoing total knee replacement surgery under sub arachnoid block |
NRS and PCA demands will be compared at 0 hours, 6 hours, 12 hours and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess consumption of rescue analgesia in the 2 aforementioned groups of patients.
2. To assess sensory deficit in the 2 aforementioned groups of patients. |
1. Rescue analgesia need will be assessed at baseline, 6 hours, 12 hours & 24 hours.
2. Sensory deficit will be assessed at 6 hours, 12 hours & 24 hours. |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
21/08/2025 |
| 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="0"
Months="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - nil
- For how long will this data be available start date provided 01-09-2025 and end date provided 17-09-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
A Randomized control study to evaluate the efficacy of dual sub sartorial block in managing post operative pain in patients undergoing unilateral total knee replacement.
Hypothesis Dual sub sartorial block facilitates adequate post operative pain management and reduction of opioid consumption in asa II and ASA III patients undergoing unilateral TKR under sub arachnoid block
Aim To understand the analgesic efficacy of dual sub sartorial block by evaluating post operative pain scores and opioid consumption in 2 groups of patients. dual sub sartorial block vs adductor canal block. To assess consumption of rescue analgesia To assess sensory deficit in both groups of patients
Study duration July 2025 to Dec 2025
single center prospective open label, randomized 2 groups post assessment clinical study
inclusion criteria ASA II III Age 30y 75y patients undergoing unilateral TKR under SAB
Exclusion criteria patient refusal to participate in the study Allergic to local anasthetic asa IV Bilateral tkr surgery under general anasthesia
sample size- 44
Group A 22 patients receiving dual sub sartorial block
Group B 22 patients receiving adductor canal block
statistical method Chi square fisher exact test student t test or any other suitable method at the time of data analysis software SPSS22 R Environment MS Excel and Word
|