| CTRI Number |
CTRI/2024/06/069537 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
24/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison in between pericapsular nerve group (PENG)and fascia iliac compartment block(FICB)will be done in fracture neck of femur posted for total hip replacement in geriatric patients for incidence of quadriceps weakness post operative for early mobilisation and discharge from hospital |
|
Scientific Title of Study
|
Comparative study of pericapsular nerve group block (PENG) VS Fascia iliaca compartment block (FICB) in Fracture neck of femur in Geriatric patient |
| 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 shiv kumar saw |
| Designation |
Junior resident |
| Affiliation |
Institute of medical sciences, Banaras Hindu University |
| Address |
First floor department of anaesthesiology, institute of medical sciences,Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9521101484 |
| Fax |
|
| Email |
Shiv.k462@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arvind bhalekar |
| Designation |
Associate Professor |
| Affiliation |
Institute of medical sciences, Banaras Hindu University |
| Address |
First floor department of anaesthesiology, institute of medical sciences,Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9717966333 |
| Fax |
|
| Email |
minearvind@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arvind bhalekar |
| Designation |
Associate Professor |
| Affiliation |
Institute of medical sciences, Banaras Hindu University |
| Address |
First floor department of anaesthesiology, institute of medical sciences,Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9717966333 |
| Fax |
|
| Email |
minearvind@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of medical science, Banaras Hindu University ,lanka (221005) Varanasi, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 shiv Kumar saw |
Trauma centre BHU |
Sir sunderlal hospital department of anaesthesiology, first floor, Banaras Hindu University
Varanasi
Uttar Pradesh
Varanasi
UTTAR PRADESH |
9521101484
Shiv.k462@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, Banaras Hindu University |
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 |
Fascia Iliaca compartment block |
For SIFIBs, patients were placed in the supine position. The linear US transducer was placed in a parasagittal orientation, medial to the anterosuperior iliac spine in order to obtain the “bow-tie†sign. The sartorius, iliacus, and internal oblique muscles were identified. Using an in-plane technique and a caudad-to-cephalad direction, the block needle was advanced until its tip was positioned between the internal oblique and iliacus muscles underneath the fascia iliaca. Following negative aspiration, the LA (40 mL 100mg of inj levobupivacaine 0.25% with inj dexamethasone 4 mg iv) was injected as the needle was slowly advanced cephalad inside fascia iliaca compartment.
Drug dose-20mg levobupivacaine
Site -local
Frequency-1 time
Intervention time- 5 minutes
|
| Comparator Agent |
Pericapsular nerve group block (PENG) |
For PENG blocks, patients were placed in the supine position. The linear Us transducer was placed in a transverse orientation, medial, and caudal to the anterosuperior iliac spine in order to identify the anteroinferior iliac spine, the iliopubic eminence, and the psoas tendon.5 Using an in-plane technique and a lateral-to-medial direction, the block needle was advanced until its tip was positioned between the periosteum and psoas tendon .The LA (20 mL , 100 mg of levobupivacaine 0.5% with dexamethasone 4 mg iv ) was injected following negative aspiration. Drug dose-20mg levobupivacaine
Site -local
Frequency-1 time
Intervention time- 5 minutes
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 and 2
Age more than 60 |
|
| ExclusionCriteria |
| Details |
Patients refusing
ASA Grade 3 and 4
Allergy to local anaesthetic
Coagulopathy , sepsis, hepatic or renal failure
Patients on any anti platelets
Patients with myopathy and neurological abnormalities
Obesity (BMI more than 40 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of quadriceps motor block post operatively |
6 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Static and dynamic pain score at 48 hours
Postoperative morphine consumption
Length of hospital stay |
Pain score at 48 hours |
|
|
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)
|
10/07/2024 |
| 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="0"
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
|
Patients those who were posted for total hip replacement use to get fascia lliaca compartment block for post op pain to decrease post op opioid consumption as it has detrimental effect on old age related dementia problems, it also caused quadriceps weakness delaying there post operative mobilisation, to tackle this we will compare this block with pericapsular nerve group block which targets the sensory supply to hip joint, this will be done after taking proper written and informed consent |