| CTRI Number |
CTRI/2024/02/063280 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
01/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Adding new Ultrasound guided blocks help in reducing pain after knee replacement surgeries |
|
Scientific Title of Study
|
comparison of analgesic efficacy of ultrasound guided genicular nerve block in combination with femoral nerve block in Primary 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 Madona Stephen |
| Designation |
Consultant anesthesiologist |
| Affiliation |
Sparsh Super Specialty Hospital |
| Address |
Sparsh Super Specialty Hospital
146 Infantry Road
Opposite to police commissioners office Bangalore
146 Infantry Road
Opposite to police commissioners office Bangalore 560001
Bangalore
KARNATAKA
560001
India |
| Phone |
9606197707 |
| Fax |
- |
| Email |
sparshclinical@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madona Stephen |
| Designation |
Consultant anesthesiologist |
| Affiliation |
Sparsh Super Specialty Hospital |
| Address |
146 Infantry Road
Opposite to police commissioners office Bangalore
Bangalore
KARNATAKA
560001
India |
| Phone |
9606197707 |
| Fax |
- |
| Email |
madonastephen25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Soujanya |
| Designation |
Research Manager |
| Affiliation |
Sparsh Super Specialty Hospital |
| Address |
146 Infantry Road
Opposite to police commissioners office Bangalore
Bangalore
KARNATAKA
560001
India |
| Phone |
9606197707 |
| Fax |
- |
| Email |
soujanya@sparshhospital.com |
|
|
Source of Monetary or Material Support
|
| Sparsh Hospital Foundation
146 Infantry Road Opposite to police commissioners office Bangalore Karnataka 560001 |
|
|
Primary Sponsor
|
| Name |
Sparsh Hospital Foundation |
| Address |
146 Infantry Road Opposite to police commissioners office Bangalore 560001 |
| 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 Madona |
Sparsh Super Speciality Hospital |
Department of Anesthesia
Third Floor 146 Infantry road opposite to police commissioners office
Bangalore
KARNATAKA |
09606197707
-
soujanya@sparshhospital.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Ethics committee sparsh Hospital |
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 |
Group 2:
Comparator Arm:
Under ultrasound guidance:
0.25% bupivacaine 10 ml as Ipack( injection between popliteal artery and capsule of knee)
0.2 % ropivacaine 10ml +25mcg dexmedetomidine as adductor canal block.
15 ml 0.25 bupivacaine with 8mg dexamethasone ( 5 ml at each genicular nerve - superomedial, superolateral and inferomedial nerve) |
CONTROL ARM
NAME OF THE PROCEDURE : Ipack( injection between popliteal artery and capsule of knee) +
Femoral nerve block
DETAILS
DOSE:
a) 0.25% bupivacaine {BRAND NAME : 0.25%ANAWIN] 10 ml as Ipack( injection between popliteal artery and capsule of knee)
b) 0.2 % ropivacaine [BRAND NAME : 0.2% ROPIN] 10ml +25mcg dexmedetomidine [ BRAND NAME :DEXEM] as femoral nerve block.
FREQUENCY : single shot injections
ROUTE OF ADMINISTRATION: Under ultrasound guidance perineural administration |
| Intervention |
Group1:
Interventional Arm:
Under ultrasound guidance:
0.25% bupivacaine 10 ml as Ipack( injection between popliteal artery and capsule of knee)
0.2 % ropivacaine 10ml +25mcg dexmedetomidine as adductor canal block.
|
INTERVENTION ARM
NAME OF THE PROCEDURE : Ipack( injection between popliteal artery and capsule of knee) +
Femoral nerve block+ genicular nerve blocks
DETAILS
DOSE:
a) 0.25% bupivacaine {BRAND NAME : 0.25%ANAWIN] 10 ml as Ipack( injection between popliteal artery and capsule of knee)
b) 0.2 % ropivacaine [BRAND NAME : 0.2% ROPIN] 10ml +25mcg dexmedetomidine [ BRAND NAME :DEXEM] as femoral nerve block.
c) Group I patients will receive 0.25% bupivacaine [ BRAND NAME : 0.25%ANAWIN] 5ml at each genicular nerve ( superomedial, inferomedial, superolateral )with 8mg dexamethasone [ BRAND NAME :DEXONA] in total.
FREQUENCY : single shot injections
ROUTE OF ADMINISTRATION: Under ultrasound guidance perineural administration
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Unilateral primary TKA
|
|
| ExclusionCriteria |
| Details |
Poorly Controlled DM(Hba1c>8)
Cirrhosis
Chronic Renal Failure
Stroke , Uncontrolled Epilepsy
History Of Post Op Delirium
History Of DVT (Therapeutic Use Of Anti-Coagulants)
Chronic Alcoholism
Chronic Smoker (1 Pack/Day Past Six Months)
History of allergy to local anaesthetics.
Cardiopulmonary Disease (Recent MI,S/P Cardio Thoracic Surgery, severe pulmonary artery hypertension,Arrythmias, ejection fraction< 40%)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effect of addition of ultrasound guided genicular nerve block to anaesthetic techniques on postoperative pain in patients undergoing total knee replacement.
|
To compare the effect of addition of ultrasound guided genicular nerve block to anaesthetic techniques on postoperative pain in patients undergoing total knee replacement.
Pain will be assessed at 6 12 18 24 & 48 hourly postoperatively by an anesthesiologist |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of addition of ultrasound guided genicular nerve blocks in patients undergoing total knee replacement on postoperative opioid requirement , ambulation & physiotherapy |
Post operative opioid consumption will be recorded during 0-6 hours, 6-12 hours,12-24 hours & 24-48 hours.
Ambulation distance was measured in feet on day 0, day 1, day 2 and day 3.
Proportion of patients receiving rescue analgesia in both groups will also be compared.
Presence of motor weakness of quadriceps if any will be noted.
|
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/03/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Total knee arthroplasty (TKA) is
a common surgical procedure that is characterized by moderate to severe
postoperative pain .
Severe pain post operatively has
been known to have detrimental impact on
patient outcome and morbidity.
Several modalities of analgesia
including nerve blocks for effective
postoperative analgesia and faster functional recovery have been discussed in
the literature. Ultrasound guided genicular nerve
blocks and radio-frequency ablation are known to provide effective analgesia in
chronic knee pain.
In this study, we aim to assess
the analgesic efficacy of combination of
genicular nerve blocks and adductor
canal block in primary total knee arthroplasty
This technique for analgesia
in TKA patients can be utilized to
improve pain scores and facilitate early ambulation, reduce the use of opioids
in perioperative period.
|