| CTRI Number |
CTRI/2024/02/062826 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
17/02/2024 |
| 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
|
A Comparison of femoral nerve block and pericapsular nerve group (PENG) block for analgesia in neck of femur fracture surgeries |
|
Scientific Title of Study
|
A Comparative study of femoral nerve block v/s pericapsular nerve group (PENG) block for perioperative analgesia in neck of femur fracture surgeries |
| 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 Aritha Anil Kumar |
| Designation |
PG resident, department of anaesthesia |
| Affiliation |
Believers church medical college kuttapuzha p.o thiruvalla |
| Address |
department of anaesthesia
believers church medical college
kuttapuzha p.o
thiruvalla
room no. 402
resident girls hostel
believers church medical college hospital
kuttapuzha p.o thiruvalla
Pathanamthitta
KERALA
689103
India |
| Phone |
7034248553 |
| Fax |
|
| Email |
arithaanilkumark@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ivan Koshy |
| Designation |
professor, department of anaesthesia |
| Affiliation |
Believers church medical college kuttapuzha p.o thiruvalla |
| Address |
department of anaesthesia
believers church medical college
kuttapuzha p.o thiruvalla
Pathanamthitta
KERALA
689103
India |
| Phone |
9539242600 |
| Fax |
|
| Email |
drivankoshy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aritha Anil Kumar |
| Designation |
PG resident department of anaesthesia |
| Affiliation |
Believers church medical college kuttapuzha p.o thiruvalla |
| Address |
department of anaesthesia
believers church medical college
kuttapuzha p.o thiruvalla
room no. 402
resident girls hostel
believers church medical college hospital
kuttapuzha p.o thiruvalla
Pathanamthitta
KERALA
689103
India |
| Phone |
7034248553 |
| Fax |
|
| Email |
arithaanilkumark@gmail.com |
|
|
Source of Monetary or Material Support
|
| Believers church medical college, Thiruvalla |
|
|
Primary Sponsor
|
| Name |
Believers church medical college |
| Address |
kuttapuzha po thiruvalla, kerala
pin 689103 |
| Type of Sponsor |
Private 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 Aritha Anil Kumar |
Believers church medical college |
department of anaesthesia,
Kuttapuzha p.o Thiruvalla
Pathanamthitta
KERALA |
7034248553
arithaanilkumark@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Believers Church Medical College Institutional Ethics Committee |
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 |
| Intervention |
femoral nerve block |
USG guided femoral nerve block is given using 23 1.5 inch needle and 0.25% bupivacaine with 4mg dexamethasone is injected. The pain is then assessed at 6 hours, 12 hours and 24 hours
|
| Comparator Agent |
pericapsular nerve group block |
USG guided PENG block is given using 23 gauge spinal needle and 0.25% bupivacaine with 4mg dexamethasone is injected.The pain is then assessed at 6 hours, 12 hours and 24 hours
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 60 years
American Society of Anesthesiologists (ASA) classification I, II, III
Patients undergoing elective proximal femoral nail anti-rotation II (PFNA2) & hemiarthroplasty
|
|
| ExclusionCriteria |
| Details |
Patients who refuse consent/lack the capacity to give consent
Patients with extremity amputation, paraplegia, or known neuromuscular diseases
Patients who are disoriented or has neurological impairment
Patient with absolute contraindication to regional anaesthesia
Patients with any known allergies to study drugs
Patients requiring post operative ICU care and mechanical ventilation
|
|
|
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 |
| perioperative analgesic effect is assessed by evaluation perioperative pain using vas score |
The pain is then assessed at 6 hours, 12 hours and 24 hours post block
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Motor Blockade following block is assessed using oxford motor grading. |
The pain is then assessed at 6 hours, 12 hours & 24 hours
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
27/02/2024 |
| 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="1"
Months="6"
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
|
This study is a randomized, double blinded , parallel group trial comparing the perioperative analgesic effect of femoral nerve block and pericapsular nerve group block(PENG) in patients undergoing surgery for neck of femur fracture. it is being conducted in India with a sample size of 100. The primary outcome is pain which is assessed using VAS score. The secondary outcome is motor blockade post block. |