| CTRI Number |
CTRI/2019/04/018651 [Registered on: 18/04/2019] Trial Registered Prospectively |
| Last Modified On: |
02/11/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Analgesic efficacy of on-arrival ultrasound guided Pericapsular Nerve Group (PENG) block vs Femoral nerve block vs femoral articular branch block in patients with unilateral hip fracture |
|
Scientific Title of Study
|
A Comparative Study of analgesic efficacy of ultrasound guided Pericapsular Nerve Group (PENG) block vs femoral nerve bock vs femoral articular branch block as an on-arrival block in patients with unilateral hip fracture |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kartik Sonawane |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Ganga Medical Centre & Hospital Pvt Ltd |
| Address |
Ganga Medical Centre & Hospital Pvt Ltd
313 MTP road
Coimbatore
313 MTP Road
Coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9561840842 |
| Fax |
|
| Email |
drkartiksonawane@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kartik Sonawane |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Ganga Medical Centre & Hospital Pvt Ltd |
| Address |
Ganga Medical Centre & Hospital Pvt Ltd
313 MTP road
Coimbatore
313 MTP Road
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9561840842 |
| Fax |
|
| Email |
drkartiksonawane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kartik Sonawane |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Ganga Medical Centre & Hospital Pvt Ltd |
| Address |
Ganga Medical Centre & Hospital Pvt Ltd
313 MTP road
Coimbatore
313 MTP Road
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9561840842 |
| Fax |
|
| Email |
drkartiksonawane@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ganga Medical Centre and Hospital Private Limited
313, Mettupallyam Road
Coimbatore 641042
Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Ganga Medical Centre and Hospital Pvt Ltd |
| Address |
313
MTP Road
Coimbatore |
| 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 Kartik Sonawane |
Ganga Medical Centre and Hospital Private Limited |
Dept. Of Anaesthesia
313
Mettupallyam Road
Coimbatore
TAMIL NADU |
9561840842
drkartiksonawane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board ( anaesthesia) Ganga Medical Centre and Hospital Private Limited |
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, (2) ICD-10 Condition: S720||Fracture of head and neck of femur, (3) ICD-10 Condition: S721||Pertrochanteric fracture, (4) ICD-10 Condition: S730||Subluxation and dislocation of hip, (5) ICD-10 Condition: S722||Subtrochanteric fracture of femur, (6) ICD-10 Condition: W19||Unspecified fall, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
On arrival Femoral Articular Branch Block |
Using 0.2% Ropivacaine or 0.25% anawin with 8 mg Dexa under a USG guidance |
| Comparator Agent |
On arrival Femoral Nerve Block |
Using 0.2% Ropivacaine or 0.25% anawin with 8 mg Dexa under a USG guidance |
| Comparator Agent |
On arrival PENG BLOCK |
Using 0.2% Ropivacaine or 0.25% anawin with 8 mg Dexa under a USG guidance |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Unilateral hip fracture
Unilateral IT Fracture
Unilateral ST fracture
Unilateral NOF fracture
Unilateral ACETABULAR fracture |
|
| ExclusionCriteria |
| Details |
Patient Refusal
Allergic to LA
Polytrauma Patient
Bilateral hip fracture
Patient with cognitive dysfunction
Mentally ill patient
Age below 10 yrs and above 90 yrs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Analgesia efficacy of PENG Block
Analgesic efficacy of Femoral Nerve Block
Analgesic efficacy of Femoral Articular Branch Block
Analgesic Efficacy of Femoral Articular Branch block |
VAS score at 0, 30, 60 minutes after Block (0-10)
At Rest and Dynamic VAS score at 0, 30, 60 minutes (0-10) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Depth of Target site
Patient Satisfaction score |
Depth in Cm
Satisfaction score 1-3, 1 unsatisfied, 2 Satisfied, 3 Fully Satisfied |
| Active Hip Flexion |
VAS score at 0, 30, 60 min ( 0-10)
Active Hip Flexion after 60 minutes in degrees (0,15,30,45,90) |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
21/04/2019 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hip fracture is associated with significant amount of pain leading to activation of neuroendocrine stressor response if severity of acute pain not controlled on time. There are lot of regional analgesia techniques available like Femoral Nerve Block, Fascia Iliaca Block, Femoral Articular Branch Block a FPS newly described PENG Block. In this study we are comparing analgesic efficacy of PENG , Femoral Nerve Block and Articular Branch Block if given as an on-arrival Block. Inclusion criteria: Unilateral hip fracture including, Fracture NOF, Fracture IT, Fracture ST, Fracture unilateral acetabulum Age from 10 yrs to 90 yrs
Study outcome: We are comparing analgesic efficacy by measuring Rest and dynamic pain score ( VAS). We are also analysing active Hip Flexion 60 minutes after Block in degrees. |