| CTRI Number |
CTRI/2021/05/033609 [Registered on: 13/05/2021] Trial Registered Prospectively |
| Last Modified On: |
10/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Proximal and mid-thigh Adductor canal block for postoperative pain relief for Total knee replacement operation |
|
Scientific Title of Study
|
Comparison of Proximal adductor canal block with mid thigh adductor canal block by Ultrasonography defined criteria for post-operative analgesia in total knee replacement surgeries. |
| Trial Acronym |
RCT ACB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mamta Sadre |
| Designation |
Senior Consultant Anaesthesiologist |
| Affiliation |
Sancheti Hospital, |
| Address |
Dept . Of Anaesthesiology , 6th floor , Sancheti Hospital
16, Shivaji Nagar,
Pune 411005
Dept. of Anaesthesiology, 5th floor, Sancheti Hospital,
16, Shivaji nagar,
Pune 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9923060340 |
| Fax |
|
| Email |
mamta.sadre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mamta Sadre |
| Designation |
Senior Consultant Anaesthesiologist |
| Affiliation |
Sancheti Hospital, |
| Address |
Depth. Of Anaesthesiology, 6th floor, Sancheti Hospital
16, Shivaji Nagar,
Pune 411005
Dept. of Anaesthesiology, 6th floor, Sancheti Hospital,
16, Shivaji nagar,
Pune 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9923060340 |
| Fax |
|
| Email |
mamta.sadre@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mamta Sadre |
| Designation |
Senior Consultant Anaesthesiologist |
| Affiliation |
Sancheti Hospital, |
| Address |
Dept. of Anaesthesiology , 6th floor, Sancheti Hospital
16, Shivaji Nagar,
Pune 411005
Sancheti Hospital,
16, Shivaji nagar,
Pune 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9923060340 |
| Fax |
|
| Email |
mamta.sadre@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sancheti Hospital |
| Address |
16, Shivaji nagar,
Pune 411005 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mamta Sadre |
6th floor OT complex , Sancheti Hospital |
16, Shivaji Nagar,Pune 411005
Pune
MAHARASHTRA |
9923060340
Mamta.sadre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
Mid-thigh Adductor canal block |
Saphenous nerve blopck at the Mid-thigh level of Adductor canal with Ropivacaine 0.375% 30 ml with Clonidine 15 ug |
| Intervention |
Proximal Adductor canal Block |
Saphenous nerve block at the intersection of medial border of Sartorius and medial border of Aductor longus muscle with Ropivacaine 0.375% 30 ml with Clonidine 15 ug |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Primary Unilateral Total Knee replacement
ASA I and II |
|
| ExclusionCriteria |
| Details |
Revision Total Knee replacement
Bilateral TKR
Neuropathic joint
Symptomatic spine
ASA III and IV |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time to first analgesia
Total opioid requirement in first 24 hours
Quadriceps strength after 5 hours |
Time to first analgesia
Total opioid requirement in first 24 hours
Quadriceps strength after 5 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of quadriceps strength |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
25/05/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We would like to compare the analgesia efficacy and quadriceps strength between two approaches of saphenous nerve block - first is Proximal adductor canal block and second is Mid-thigh adductor canal block. Time to first analgesia will be noted and total opioid dose requirement during first 24 hours will be noted. quadriceps strength will be assessed 5 hours after block. |