| CTRI Number |
CTRI/2019/05/018988 [Registered on: 07/05/2019] Trial Registered Prospectively |
| Last Modified On: |
03/10/2020 |
| 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
|
Comparison of pain management techniques in cases of Total Knee Replacement surgeries |
|
Scientific Title of Study
|
Comparing adductor canal block and multisite infiltration analgesia (intra-articular and peri-articular) in efficient pain control among the cases of unilateral total knee replacement;a prospective randomized controlled trial |
| Trial Acronym |
RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Surg Lt Cdr Dr Pothireddy Sreenivasulu |
| Designation |
Resident |
| Affiliation |
AFMC, Pune |
| Address |
Dept of Anaesthesiology and Critical Care,
AFMC, Pune
Officers mess, AFMC, Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
8331891329 |
| Fax |
|
| Email |
pothireddy.srinu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Surg Lt Cdr Dr Pothireddy Sreenivasulu |
| Designation |
Resident |
| Affiliation |
AFMC, Pune |
| Address |
Dept of Anaesthesiology and Critical Care,
AFMC, Pune
Officers mess, AFMC, Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
8331891329 |
| Fax |
|
| Email |
pothireddy.srinu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Surg Lt Cdr Dr Pothireddy Sreenivasulu |
| Designation |
Resident |
| Affiliation |
AFMC, Pune |
| Address |
Dept of Anaesthesiology and Critical Care,
AFMC, Pune
Officers mess, AFMC, Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
8331891329 |
| Fax |
|
| Email |
pothireddy.srinu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical College, Wanowrie, Pune |
|
|
Primary Sponsor
|
| Name |
AFMC Pune |
| Address |
Armed Forces Medical College, Wanawadi, Pune |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Brig S Sawhney |
Command hospital, Wanowrie, Pune |
Dept of Orthopedics, ward no.24
Pune
MAHARASHTRA |
9971522244
drsadhan@gmail.com |
| Lt Col Dr Krishna Prasad |
Military Hospital, Kirkee, Pune |
Joint replacement centre, Dept of Orthopedics
Pune
MAHARASHTRA |
9024130145
drkaypee99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, Armed forces medical college, Pune |
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 |
| Intervention |
Adductor canal block using 0.5% Bupivacaine |
Adductor canal block using 0.5% Bupivacaine in patients undergoing unilateral total knee replacement |
| Comparator Agent |
Cocktail of drugs for multisite infiltration of knee joint |
Cocktail of drugs (15 ml.0.5% Bupivacaine+5 ml 2% Lignocaine with Adr + 7.5 mg Morphine + 4 mg Dexamethasone + 20 ml NS) used for intra-articular and peri-articular infiltration of knee joint in patients undergoing unilateral total knee replacement. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age upto 80 yrs, American society of anaesthesiologists grade I to III, Body mass index 18-30 kg/m2 |
|
| ExclusionCriteria |
| Details |
Patients with comorbidities (morbid obesity, muscular dystrophy, history of stroke or major neurological deficit, sensory and motor disorders etc.., allergic to LAs and opioids, chronic pain requiring opioid medication, bilateral total knee replacement |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time for rescue analgesic, total amount of analgesic required keeping the patient pain free during 48 hours of postoperative period, NRS score |
1 yr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total amount of analgesic required keeping the patient pain free during 48 hours of postoperative period, NRS score |
1 yr |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
13/05/2019 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Most of the previous studies compared the analgesic and other post-op outcomes of various techniques used for early rehabilitation of patients who underwent TKR. Study involving comparison of MIA and ACB is warranted for adoption at Command hospital, Pune and Military hospital, Kirkee. Thus study which will be conducted at entirely proficient and amply loaded tertiary Orthopedic centres will add to the literature explaining the efficiency of the pain management techniques in Total Knee Replacement.
|