| CTRI Number |
CTRI/2024/11/077483 [Registered on: 29/11/2024] Trial Registered Prospectively |
| Last Modified On: |
22/12/2024 |
| 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
|
Which Nerve Block Combination Offers Better Pain Relief After Total Hip Replacement Surgery: (PENG) pericapsular nerve group + Lateral Femoral Cutaneous Nerve (LFCN ) vs. Femoral Nerve + Lateral Femoral Cutaneous Nerve (LFCN ) |
|
Scientific Title of Study
|
Comparison Of Combination Of Pericapsular Nerve Group (PENG) Block And Lateral Femoral Cutaneous Nerve (LFCN ) Block Vs Combination Of Femoral Nerve Block And LFCN Block For Post Op Analgesia And Satisfaction For Total Hip Replacement Surgery (THR). |
| 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 HRIDAYESH KUMAR |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE PGIMER
NEHRU BULDING 4TH FLOOR
CHANDIGARH INDIA
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7800111194 |
| Fax |
|
| Email |
drhridayeshkumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AMIT KUMAR SHARMA |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh, India |
| Address |
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE PGIMER
NEHRU BULDING 4TH FLOOR
CHANDIGARH INDIA
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8699076561 |
| Fax |
|
| Email |
amitkalayat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR AMIT KUMAR SHARMA |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh, India |
| Address |
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE PGIMER
NEHRU BULDING 4TH FLOOR
CHANDIGARH INDIA
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8699076561 |
| Fax |
|
| Email |
amitkalayat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research (PGIMER), Sector 12 , Chandigarh Pin : 160012 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia and Intensive Care PGIMER Chandigarh |
| Address |
4TH FLOOR NEHRU BUILDING Department of Anaesthesia and Intensive Care, PGIMER Chandigarh |
| 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 HRIDAYESH KUMAR |
Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh |
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE PGIMER NEHRU BULDING 4TH FLOOR
Chandigarh
CHANDIGARH |
7800111194
drhridayeshkumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER INSTITUTIONAL ETHICS COMMITTEE INTRAMURAL CHANDIGARH |
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 |
Femoral and LFCN block |
FN block using 0.2% ropivacaine with dexamethasone 1 mcg/kg (20 ml) and LFCN block 0.2% ropivacaine 3 ml will be performed by placing linear ultrasound probe. |
| Intervention |
PENG and LFCN block |
Pericapsular nerve block (PENG) block 0.2% ropivacaine with dexamethasone 1 mcg/kg (20 ml )and LFCN block 0.2% ropivacaine 3 ml would be performed using low frequency curvilinear ultrasound probe after administration of spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 patients.
THR patients will be included
|
|
| ExclusionCriteria |
| Details |
Emergency surgery
CKD
Bleeding diathesis or patients on anticoagulant
Traumatic THR
any psychiatric illness.
Not willing for the procedures.
Allergy to drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare percentage of patients with mild pain on hip flexion of 30 degree at 6 hours after the surgery |
6 hours after completion of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of analgesia
Incidence of adverse events
Patient satisfaction and quality of recovery
Area under the curve of the numeric rating scale for pain
Time to mobilization discharge from postoperative care unit and home readiness |
till the patient discharge from the hospital |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/12/2024 |
| Date of Study Completion (India) |
15/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 hip replacement (THR) is a widely performed surgery designed to relieve hip joint pain and improve function by replacing the joint with a prosthetic implant. Effective postoperative pain management is essential, as it not only enhances comfort but also enables quicker mobilization. Pain management strategies typically include opioid-based analgesics and regional anesthesia techniques, such as femoral nerve blocks, fascia iliaca compartment blocks, and more recently, the pericapsular nerve group (PENG) block, introduced in 2018. Unlike other blocks, PENG specifically targets hip sensory nerves, potentially reducing opioid requirements and promoting faster recovery due to its minimal impact on motor function. Combining PENG with a lateral femoral cutaneous nerve (LFCN) block has shown even better pain relief, addressing both hip and thigh discomfort. This study aims to compare the effectiveness of combining femoral and LFCN blocks with the PENG and LFCN block combination in managing THR postoperative pain |