| CTRI Number |
CTRI/2024/08/071765 [Registered on: 01/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Is analgesic efficacy of dual subsartorial block superior than adductor canal block with local infiltration analgesia in patients undergoing total knee arthroplasty |
|
Scientific Title of Study
|
Comparison of Analgesic Efficacy of Dual Subsartorial Block and Adductor Canal Block with Local Infiltration Analgesia in Patients Undergoing Total Knee Arthroplasty |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Supreeth L |
| Designation |
PG Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of anesthesia and intensive care, VMMC and Safdarjung
hospital,Ansari nagar East,New Delhi
New Delhi
DELHI
110029
India
South
DELHI
110029
India |
| Phone |
07019561728 |
| Fax |
|
| Email |
supreethl369@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranju Gandhi |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of anesthesia and intensive care, VMMC and Safdarjung
hospital,Ansari nagar East,New Delhi
New Delhi
DELHI
110029
India
South
DELHI
110029
India |
| Phone |
09818941341 |
| Fax |
|
| Email |
icu_era@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Supreeth L |
| Designation |
PG Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of anesthesia and intensive care, VMMC and Safdarjung
hospital,Ansari nagar East,New Delhi
New Delhi
DELHI
110029
India
South
DELHI
110029
India |
| Phone |
07019561728 |
| Fax |
|
| Email |
supreethl369@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital
near AIIMS Hospital, Ansari Nagar West, New Delhi, Delhi,India 110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Ansari nagar East,New Delhi
New Delhi
DELHI
110029
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 Supreeth L |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of anesthesia and intensive care, VMMC and Safdarjung
hospital,Ansari nagar East,New Delhi
New Delhi
DELHI
110029
India
South
DELHI |
7019561728
supreethl369@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College and Safdarjung Hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Adductor canal block with Local infiltration analgesia |
Group B: 60 ml Ropivacaine 0.2% with 8 mg dexamethasone (10ml in the adductor canal and 50 ml local infiltration analgesia) applied once Post operatively
Given once
Neuraxial blockade
10-30 mins duration of therapy |
| Intervention |
Dual subsartorial block |
Group A: 30 ml Ropivacaine 0.2% with 8 mg dexamethasone (10 ml in the distal femoral triangle and 20 ml in the adductor canal)
Given once
Neuraxial blockade
10-30 mins duration of therapy |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 25-80 years
2. American society of anaesthesiologists (ASA) Grade I – III
3. Elective unilateral TKA with varus knee or mild valgus deformity via medial approach
|
|
| ExclusionCriteria |
| Details |
1. Neurological deficit, cognitive dysfunction, operated limb neuropathy
2. Previously operated patients posted for redo total knee arthroplasty
3. Hypersensitivity to local anaesthetic agent or any of the study medications
4. Any contraindications of neuraxial blockade or local site infection
5. Inability to understand visual analogue scale (VAS) for pain
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the analgesic efficacy of dual subsartorial block and adductor canal block with local infiltration analgesia for complete pain relief using the postoperative visual analog scale in patients undergoing total knee arthroplasty. |
6 hrly for first 24 hours and 12 hourly till 72 hours postoperatively) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To measure the operated limb strength between groups using Medical Research Council scale every six hourly |
6 hrly for first 24 hours and 12 hourly till 72 hours postoperatively) |
| 2. To find the timing of first rescue analgesic and calculate total postoperative tramadol consumption between groups |
Till 72hrs |
| 3. To determine the sensory duration of the block. |
Till discharge |
| 4. To map the site of postoperative knee pain and character of pain . |
Till discharge |
| 6. Time to ambulation in the postoperative period. |
Till discharge |
| o determine the total postoperative length of hospitalization. |
Till discharge |
| To determine patient’s overall satisfaction score at discharge using 0-5 score |
At discharge |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
11/08/2024 |
| 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="11"
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
|
COMPARISON OF ANALGESIC EFFICACY OF DUAL SUBSARTORIAL BLOCK 30 ml Ropivacaine 0.2% with 8 mg dexamethasone (10 ml in the distal femoral triangle and 20 ml in the adductor canal) AND ADDUCTOR CANAL BLOCK WITH LOCAL INFILTRATION ANALGESIA 60 ml Ropivacaine 0.2% with 8 mg dexamethasone (10ml in the adductor canal and 50 ml local infiltration analgesia) IN PATIENTS UNDERGOING TOTAL KNEE ARTHROPLASTY |