| CTRI Number |
CTRI/2022/04/041587 [Registered on: 01/04/2022] Trial Registered Prospectively |
| Last Modified On: |
31/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Postoperative pain management after total hip replacement |
|
Scientific Title of Study
|
Comparison of pericapsular nerve group(PENG) block and femoral nerve block for postoperative analgesia after total hip arthroplasty |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sidharth Sraban Routray |
| Designation |
Assoc Prof |
| Affiliation |
scb medical college,cuttack |
| Address |
Dpt of anesthesiology,scb medical college,cuttack,odisha
Cuttack
ORISSA
743001
India
Cuttack
ORISSA
753001
India |
| Phone |
9437031992 |
| Fax |
|
| Email |
drsidharth74@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sidharth Sraban Routray |
| Designation |
Assoc Prof |
| Affiliation |
scb medical college,cuttack |
| Address |
Dpt of anesthesiology,scb medical college,cuttack,odisha
Cuttack
ORISSA
743001
India
Cuttack
ORISSA
753001
India |
| Phone |
9437031992 |
| Fax |
|
| Email |
drsidharth74@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sidharth Sraban Routray |
| Designation |
Assoc Prof |
| Affiliation |
scb medical college,cuttack |
| Address |
Dpt of anesthesiology,scb medical college,cuttack,odisha
Cuttack
ORISSA
743001
India
Cuttack
ORISSA
753001
India |
| Phone |
9437031992 |
| Fax |
|
| Email |
drsidharth74@gmail.com |
|
|
Source of Monetary or Material Support
|
|
SCB Medical college Hospital,cuttack |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [Not sponsored by any body] |
|
|
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 |
| Sidharth Sraban Routray |
SCB Medical college and Hospital,cuttack,Odisha |
Sidharth Sraban Routray,Assoc prof, Department of Anesthesiology and critical care
Cuttack
ORISSA
Cuttack
ORISSA |
9437031992
drsidharth74@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: M165||Unilateral post-traumatic osteoarthritis of hip, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group F will receive femoral nerve block |
High frequency (5-10 MHz) linear ultrasound transducer will be used.Probe will be placed over the inguinal crease and femoral nerve will be visualized and 20 ml of ropivacaine 0.75% will be injected |
| Comparator Agent |
Group P will receive PENG block |
Low frequency (2.5-5MHz) curvilinear probe will be placed over the aterior inferior iliac spine.Using a 21G 100mm needle,subpsoas fascial plane will be identified and 20 ml f ropivacaine 0.75% will be injected. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I/II
Patients posted for total hip replacement. |
|
| ExclusionCriteria |
| Details |
Bleeding disorders
Allergy to ropivacaine
Severe obesity(BMI>35Kg/sqm
Cognitive impairment
language barrier |
|
|
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 |
| Postoperative VAS pain score |
At 4hrs postoperatively on day 0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
VAS pain score
postoperatively,Postoperative quadriceps strength,patient satisfaction |
on day 1 |
|
|
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)
|
08/04/2022 |
| 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
|
Will send for publication after completion of study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
3 IN 1 femoral nerve block is commonly used for postoperative analgesia after total hip replacement.but it has demerits like not so effective prolonged analgesia and quadriceps weakness.The pericapsular nerve group (PENG) block is a new technique and it may produce better analgesia with preservation of motor function.We will compare both femoral nerve block and PENG block for postoperative analgesia and quadriceps strength after total hip replacement surgery. |