| CTRI Number |
CTRI/2018/08/015386 [Registered on: 20/08/2018] Trial Registered Prospectively |
| Last Modified On: |
04/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study comparing two methods of intervention for pain control following total knee replacement |
|
Scientific Title of Study
|
Randomised Double-Blind Placebo Controlled clinical trial to compare the efficacy of Adductor Canal Block versus Adductor canal block plus Intra-articular catheter for pain control following Total Knee Arthroplasty |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vivek Chandak |
| Designation |
Fellow in Arthroplasty |
| Affiliation |
Sunshine Hospitals |
| Address |
Room no.1, Sunshine Hospitals, Pendarghast Road, Near paradise Circle, Secunderabad
Hyderabad
ANDHRA PRADESH
500003
India |
| Phone |
7003043431 |
| Fax |
|
| Email |
drvivekchandak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Chandak |
| Designation |
Fellow in Arthroplasty |
| Affiliation |
Sunshine Hospitals |
| Address |
Room no.1, Sunshine Hospitals, Pendarghast Road, Near paradise Circle, Secunderabad
Hyderabad
ANDHRA PRADESH
500003
India |
| Phone |
7003043431 |
| Fax |
|
| Email |
drvivekchandak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivek Chandak |
| Designation |
Fellow in Arthroplasty |
| Affiliation |
Sunshine Hospitals |
| Address |
Room no.1, Sunshine Hospitals, Pendarghast Road, Near paradise Circle, Secunderabad
Hyderabad
ANDHRA PRADESH
500003
India |
| Phone |
7003043431 |
| Fax |
|
| Email |
drvivekchandak@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sunshine Hospitals, Secunderabad |
|
|
Primary Sponsor
|
| Name |
Sunshine Hospitals |
| Address |
Pendarghast Road, near Paradise circle, Secunderabad, Andhra Pradesh, 500003 |
| 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 Vivek Chandak |
Sunshine Hospitals |
Pendarghast road, near Paradise circle, Secunderabad, 500003
Hyderabad
ANDHRA PRADESH |
7003043431
drvivekchandak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sunshine Hospita |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, (2) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NORMAL SALINE |
Dose: 0.9% of 20 ml normal saline
Frequency : Every 6th hour for 24 hours
Route of administration: Intra-articular to knee joint
Duration of Therapy: 24 hours post operatively |
| Intervention |
Ropivacaine |
Dose: 0.2% of 20 ml Ropivacaine
Frequency : Every 6th hour for 24 hours
Route of administration: Intra-articular to knee joint
Duration of Therapy: 24 hours post operatively |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing Unilateral Primary Total Knee Replacement at Sunshine Hospitals, Secunderabad |
|
| ExclusionCriteria |
| Details |
Revision Knee Replacements, Bilateral/Staggered Knee Replacement, Creatinine>2, Infected Cases, Gross Deformity (varus>20 degrees, Fixed Flexion Deformity>15 degrees) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PAIN RELIEF AS MEASURED BY VAS SCORE |
every 8th hourly following surgery for 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| RANGE OF MOTION AS MEASURED BY GONIOMETER |
24 HORS POST SURGERY |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
30/08/2018 |
| Date of Study Completion (India) |
30/11/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
HYPOTHESIS : Better pain relief and Range of Motion with Adductor Canal Block + Intra-articular catheter (ACB + IAC) than Adductor Canal Block alone AIM : 1. To study the effectiveness of our Multimodal Pain control regime in pain management and early rehabilitation 2.To determine which of the following method provides effective pain relief and improvement in post-operative ROM Group A: Adductor Canal Block + Intra-articular catheter (ACB +IAC) Group B: Adductor Canal Block (ACB)
METHODOLOGY: Sample size – 120 patients, each group 60 patients, Group A: Adductor canal block + Intra-articular catheter group with anaesthetic drug, Group B: Adductor canal Block + Intra-articular Catheter group with placebo (normal saline)
Randomization will be done through random numbers generated according to software. Sealed envelope will be made. Patients will not be aware of the Group they are in. Data analysis team will also be blinded from the study. Data collection : VAS ( Visual Analog Score) to be collected at Post operative Day 0 and Day 1 every 8th hourly; Knee Range of motion will be collected at post operative Day 1.
|