| CTRI Number |
CTRI/2024/06/069175 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
24/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Compare pain efficacy with and without iliopsoas plane block in patients undergoing total hip arthroplasty |
|
Scientific Title of Study
|
Analgesic Efficacy of Iliopsoas Plane Block in Total Hip Arthroplasty : A Randomised Controlled Trial |
| 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 Ashmi Latheef |
| Designation |
Junior resident |
| Affiliation |
AIIMS PATNA |
| Address |
Department of Anaesthesiology, OT complex,IPD, 5th floor, AIIMS PATNA, Phulwarisharif, Patna
Bihar
Patna
BIHAR
801507
India |
| Phone |
8848755765 |
| Fax |
|
| Email |
latheefashmi2022@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajeet Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS PATNA |
| Address |
Department of Anaesthesiology, OT complex IPD 5th floor, AIIMS PATNA, Phulwarisharif, Patna
Patna
BIHAR
801507
India |
| Phone |
9312501413 |
| Fax |
|
| Email |
ajeetanaes@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajeet Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS PATNA |
| Address |
Department of Anaesthesiology, OT complex IPD 5th floor, AIIMS PATNA, Phulwarisharif, Patna
Patna
BIHAR
801507
India |
| Phone |
9312501413 |
| Fax |
|
| Email |
ajeetanaes@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, AIIMS PATNA, Phulwarisharif, Patna, Bihar, pin 801507 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Patna |
| Address |
Department of Anaesthesiology, 5th floor OT complex, AIIMS PATNA, Phulwarisharif, Patna |
| 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 Ashmi Latheef |
All India Institute of Medical Sciences, Patna |
Department of Anaesthesiology,
OT complex IPD 5th floor, AIIMS PATNA, Phulwarisharif, Patna
Patna
BIHAR |
8848755765
latheefashmi2022@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, AIIMS PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, (2) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, (3) ICD-10 Condition: M161||Unilateral primary osteoarthritisof hip, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
General anaesthesia given without any block |
No block will be given in this group. Opioid consumption will be assessed postoperatively after giving plane GA. |
| Intervention |
Iliopsoas Plane Block |
Single dose of 10ml 0.5% ropivacaine is given in iliopsoas plane after induction of general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients planned for total hip arthroplasty
ASA I, II, III patients
Age group 20- 70 years |
|
| ExclusionCriteria |
| Details |
Patient refusal
ASA IV
High risk patients who may require post operative ICU care
Infection over target site
Bleeding diathesis
Allergic to local anaesthetic |
|
|
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 |
| To compare the postoperative opioid consupmtion with and without iliopsoas plane 24hr post operatively |
At 1hr, 6hr, 12hr, 24hr postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative time to 1st rescue analgesia |
from the time of administration of block to the first need of resue analgesic administration |
| NRS score at 1hr 6hr 12hr 24hr postoperatively |
At 1hr, 6hr, 12hr, 24hr postoperatively |
| Muscle power at 1hr 6hr 12hr 24hr postoperatively |
At 1hr, 6hr, 12hr,24 hr postoperatively |
| Patient satisfaction |
24 hr postoperatively |
| Postoperative nausea and vomiting |
24 hr postoperatively |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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 4 |
|
Date of First Enrollment (India)
|
30/06/2024 |
| 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="2"
Months="0"
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
Modification(s)
|
Total hip arthroplasty is a major orthopaedic procedure associated with significant postoperative pain. Many regional anaesthetic techniques are available to reduce postoperative pain and opioid consumption, most of it causes motor weakness. Iliopsoas plane block is a recently developed motor sparing regional anaesthesia technique the targets the sensory branches from the femoral and accessory obturator nerve there by increases the patient outcome in terms of recovery, early mobilisation and satisfaction. There is lack of enough evidence for analgesic efficacy of iliopsoas plane block. In this study we compare the 24hr post operative opioid consumption with and without iliopsoas plane block in patients undergoing total hip arthroplasty under general anaesthesia |