| CTRI Number |
CTRI/2022/09/045720 [Registered on: 21/09/2022] Trial Registered Prospectively |
| Last Modified On: |
20/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Nerve block for hip surgery |
|
Scientific Title of Study
|
Comparative study of efficacy of Ultrasound guided Pericapsular Nerve Group block combined with Lateral Femoral Cutaneous Nerve of thigh and Pericapsular Nerve block alone for postoperative pain relief in patients undergoing surgeries for fractures around the hip joint |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mitlesh Kumar |
| Designation |
DNB resident |
| Affiliation |
Tata Main Hospital, Jamshedpur |
| Address |
Department Of Anaesthesiology . JGMH building , Main Operation Theatre , 2nd foor , 831001
Purbi Singhbhum
JHARKHAND
831001
India |
| Phone |
9114477096 |
| Fax |
|
| Email |
bossbaby1410@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srividhya |
| Designation |
Senior Consultant , Department Of Anaesthesiology |
| Affiliation |
Tata Main Hospital, Jamshedpur |
| Address |
TATA MAIN hospital , JGMH building , Department of Anesthesiology
TATA MAIN hospital , JGMH building , Department of Anesthesiology
Purbi Singhbhum
JHARKHAND
831005
India |
| Phone |
09835172882 |
| Fax |
|
| Email |
vidhyatmh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srividhya |
| Designation |
Senior Consultant , Department Of Anaesthesiology |
| Affiliation |
Tata Main Hospital, Jamshedpur |
| Address |
TATA MAIN hospital , JGMH building , Department of Anesthesiology
TATA MAIN hospital , JGMH building , Department of Anesthesiology
Purbi Singhbhum
JHARKHAND
831005
India |
| Phone |
09835172882 |
| Fax |
|
| Email |
vidhyatmh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Main Hospital Jamshedpur
Department Of Anaesthesiology . JGMH building , Main Operation Theatre , 2nd foor , 831001 |
|
|
Primary Sponsor
|
| Name |
Tata Main Hospital Jamshedpur |
| Address |
Department Of Anaesthesiology . JGMH building , Main Operation Theatre , 2nd foor , 831001 |
| 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 |
| Mitlesh Kumar |
Tata Main Hospital |
Department Of Anaesthesiology . JGMH building , Main Operation Theatre , 2nd foor , 831001
Purbi Singhbhum
JHARKHAND |
9114477096
bossbaby1410@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE , TATA MAINS HOSPITAL , JAMSHEDPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M800||Age-related osteoporosis with current pathological fracture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
PENG block alone USG guided |
PENG block USG guided is given 10 minutes before Spinal anaesthesia in orthopedic surgery of hip fracture |
| Intervention |
PENG block along with LFCN block USG guided |
PENG block along with LFCN block USG guided is given 10 minutes before Spinal anaesthesia in orthopedic surgery of hip fracture |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective surgery for fracture around the hip joint
ASA grade I , II , III |
|
| ExclusionCriteria |
| Details |
1. Patients refusing to participate in study
2. Patients with allergy to Local anaesthetics
3. Patients with coagulopathy , infection at site of block
4. Patients with neurological deficits
5. Patients with pschiatric illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the rest and dynamic pain scores ( VAS )within first 24 hours |
june 2022 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the duration of analgesia in both groups ( time of administration of block till VAS greater or equal to 4 |
june 2022 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
21/09/2022 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bossbaby1410@gmail.com].
- For how long will this data be available start date provided 21-03-2022 and end date provided 04-03-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Fractures around the hip Joint are common fractures occurring in the elderly population which have significant degree of morbidity and mortality . A good postoperative pain relief after surgical management under subarachnoid block is required for early recovery and mobilization . Multimodal analgesia with paracetamol , NSAIDS , opioids and the newer ultrasonography guided nerve blocks are the mainstay of management .Two such Ultrasound guided nerve blocks are PENG block and LFCN block are both being used alone or in combination . Hence study undertaken to compare the efficacy of postoperative pain relief of PENG block with LFCN block vs PENG block alone. |