| CTRI Number |
CTRI/2024/01/061612 [Registered on: 18/01/2024] Trial Registered Prospectively |
| Last Modified On: |
05/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ease of spinal positioning with the use two different blocks. |
|
Scientific Title of Study
|
Comparison of pericapsular nerve group block and femoral nerve block for ease of positioning during spinal anaesthesia in hip 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 Tarun Yadav |
| Designation |
Associate Professor |
| Affiliation |
Pt BDS PGIMS ROhtak |
| Address |
Department of Anaesthesiology,
Room no 25, Second Floor, New OT Complex, Pt BDS PGIMS,Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8826444011 |
| Fax |
|
| Email |
drtarunyadav@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tarun Yadav |
| Designation |
Associate Professor |
| Affiliation |
Pt BDS PGIMS ROhtak |
| Address |
Department of Anaesthesiology,
Room no 25, Second Floor, New OT Complex, Pt BDS PGIMS,Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8826444011 |
| Fax |
|
| Email |
drtarunyadav@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Himadri Chanda |
| Designation |
Junior Resident |
| Affiliation |
Pt BDS PGIMS Rohtak |
| Address |
Department of Anaesthesiology,
Room no 25, Second Floor, New OT complex,Pt BDS PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
7568532081 |
| Fax |
|
| Email |
himadrichanda1992@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government of Haryana,
Pandit Bhagwant Dayal Sharma Post Graduate Institute of Medical Science Rohtak Haryana |
|
|
Primary Sponsor
|
| Name |
Government of Haryana _ Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
PGIMS Campus, Rohtak, Haryana 12401 |
| Type of Sponsor |
Government 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 Tarun Yadav |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak |
Room no 25, Second
Floor, Deptt of
Anaesthesiology, New
Operation Theatre Complex
Rohtak
HARYANA |
8826444011
drtarunyadav@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee Pt. B.D. Sharma PGIMS/UHS, Rohtak |
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 |
| Comparator Agent |
Femoral nerve block |
Group FNB - who will receive femoral nerve block preoperatively prior to spinal anaesthesia.
Duration of application of block- 10 mins |
| Intervention |
Pericapsular nerve group block |
Group PENG - who will receive pericapsular nerve group block preoperatively prior to spinal anaesthesia.
Duration of application of block - 10 mins |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged between 18-85 years, of either sex, unilateral hip fracture belonging to ASA Physical status I-III scheduled for hip fracture surgery under spinal anaesthesia will be included in the study. |
|
| ExclusionCriteria |
| Details |
Patients having bleeding tendency, multiple site fractures, on anticoagulant therapy, peripheral neuropathy, fractures older than one week, allergy to amide local anaesthetics, mental disorders, local infection at injection site, inability to rate pain score by any reason and patients who refuse to participate in study will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare analgesic effects of Pericapsular nerve group block (PENG) and Femoral nerve block(FNB) for positioning of spinal anaesthesia. |
-Baseline
-20 mins after Regional Block
-30 min after Regional Block
-During Spinal Anaesthesia Positioning |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare quality of positioning for spinal anaesthesia after administration of Pericapsular nerve group block (PENG) and Femoral nerve block (FNB). |
-During Spinal Anaesthesia Positioning |
| To compare post operative analgesia among Pericapsular nerve group block (PENG) and Femoral nerve block (FNB). |
-4hr Postoperatively
-24hr Postoperatively |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/01/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Title : Comparison of pericapsular nerve group block and femoral nerve block for ease of positioning during spinal anaesthesia in hip fracture surgeries.
Aim : Comparison of pericapsular nerve group block and femoral nerve block for ease of positioning during spinal anaesthesia in hip fracture. surgeries.
Primary Objective :To evaluate and compare analgesic effects of Pericapsular nerve group block (PENG) and Femoral nerve block(FNB) for positioning of spinal anaesthesia.
Secondary objectives:
1. To compare quality of positioning for spinal anaesthesia after administration of Pericapsular nerve group block (PENG) and Femoral nerve block.
2. To compare post operative analgesia among Pericapsular nerve group block (PENG) and Femoral nerve block.
Inclusion criteria: Adult patients aged between 18-85 years, of either sex, unilateral hip fracture belonging to ASA Physical status I-III scheduled for hip fracture surgery under spinal anaesthesia will be included in the study.
Exclusion criteria: Patients having bleeding tendency, multiple fractures, on anticoagulants therapy, peripheral neuropathy, fractures older than one week, allergy to amide local anaesthetics, mental disorders, local infection at injection site, inability to rate pain score by any reason and patients who refuse to participate in study will be excluded.
Sample Size: 70 patients (35 in each group).
Group allocation :
Group PENG (n=35) will receive PENG block before spinal anaesthesia.
Group FNB (n=35) will receive Femoral nerve block before spinal anaesthesia.
Assessment :
Analgesic effects of Pericapsular nerve group block (PENG) and Femoral nerve block(FNB).
Quality of positioning for spinal anaesthesia after administration of Pericapsular nerve group block (PENG) and Femoral nerve block.
Post operative analgesic effects Pericapsular nerve group block (PENG) and Femoral nerve block.
Analysis :
Data will be compiled, compared and appropriate statistical test will be applied to analyse the results. |