| CTRI Number |
CTRI/2024/05/066763 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
02/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Prior to positioning the patients for spinal anaesthesia to achieve a pain free positioning pericapsular nerve group block (PENG) and Femoral block is performed and compared in patients those are undergoing hip surgeries.It is a double -blinded randomised control trial |
|
Scientific Title of Study
|
Pre-operative peri-capsular nerve group (PENG) block and femoral nerve block for positioning for spinal anaesthesia for hip fracture surgeries- A double- blinded randomized control trial |
| 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 sushrutha R |
| Designation |
Junior Resident |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
Department of Anaesthesiology
1st floor, hospital block,
Sri Manakula vinayagar medical college and hospital, kalitheerthalkuppam, madagadipet, puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
7339279223 |
| Fax |
|
| Email |
sushrutha3112@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sushrutha R |
| Designation |
Junior Resident |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
Department of Anaesthesiology
1stfloor , hospital block,
Sri Manakula vinayagar medical college and hospital, kalitheerthalkuppam, madagadipet, puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
7339279223 |
| Fax |
|
| Email |
sushrutha3112@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr sushrutha R |
| Designation |
Junior Resident |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
Department of Anaesthesiology
1st floor, hospital block,
Sri Manakula vinyagar medical college and hospital, kalitheerthalkuppam, madagadipet, puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
7339279223 |
| Fax |
|
| Email |
sushrutha3112@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri manakula vinyagar medical College and hospital |
|
|
Primary Sponsor
|
| Name |
Sushrutha R |
| Address |
Sri manakula vinyagar medical College and hospital |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| sushrutha |
Sri manakula vinyagar medical College and hospital |
Department of Anaesthesiology 1st floor, hospital block,
Sri manakula vinyagar medical College and hospital,madagadipet, puducherry
Pondicherry
PONDICHERRY |
7339279223
sushrutha3112@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Smvmch ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M848||Other disorders of continuity of bone, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.25%Bupivacaine-20ml
|
0.25% bupivacaine -20ml
Duration-30mins |
| Comparator Agent |
Femoral nerve block |
Femoral block given with 0.25% Bupivacaine -20ml |
| Comparator Agent |
Pericapsular nerve group (PENG) block |
Pericapsular nerve block is given with 0.25% BUPIVACAINE -20ML |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anaesthesiology physical status I-III
Patients willing for the study |
|
| ExclusionCriteria |
| Details |
Allergic to local anaesthetics, bleeding disorders or coagulopathies hypersensitivity reactions |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the analgesic efficacy of PENG and femoral block for positioning the patients for spinal anaesthesia with hip fracture surgeries by using visual analogue scale (VAS) after performing the blocks.
|
To compare the analgesic efficacy of PENG and femoral block for positioning the patients for spinal anaesthesia with hip fracture surgeries by using visual analogue scale (VAS) after performing the blocks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time needed for spinal anaesthesia performance measured from start of positioning manoeuvres to the spinal needle removal |
Minutes |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/05/2024 |
| 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
|
Pericapsular nerve group (PENG) block is a novel approach introduced in 2018 by L.Giron-Aringo et al especially for hip surgeries provide post operative analgesia at the hip capsule and providing peri operative anaesthesia for positioning the patient for spinal anaesthesia who are undergoing hip surgeries wherein the articular branches of femoral nerve , obturator nerve and accesory obturator nerve supplying the anterior hip capsule are blocked. Peri capsular nerve group is a newer technique with motor soaring characteristics . Femoral nerve block is a safe, simple technique widely used analgesia for proximal femur fracture surgeries. Studies have reported NRS pain score reduction of 7 points out of 10 compared with baseline of intravenous opiates only for analgesia. They noted a purely sensory blockade, so without motor impairment. Although, additional series have not included large number of patients either. Therefore, in this study we compare the immediate analgesic efficacy of these two blocks for patient positioning for spinal anaesthesia under ultra sound guided approach. |