| CTRI Number |
CTRI/2024/09/074427 [Registered on: 26/09/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
To compare Pericapsular nerve group block and Suprainguinal fascia iliaca compartment block for pain reduction during positioning patients with hip fractures for spinal anaesthesia |
|
Scientific Title of Study
|
Comparison of Pericapsular nerve group block and Suprainguinal fascia iliaca compartment block for reduction of pain during positioning patients with hip fractures for Spinal anaesthesia : A Prospective Randomised Blinded Study |
| 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 Abhilekha Choudhury |
| Designation |
Post Graduate Trainee |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care, Gauhati Medical College, Bhangagarh, Guwahati
Kamrup
ASSAM
781032
India |
| Phone |
9508465588 |
| Fax |
|
| Email |
abhilekha18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyam Saikia |
| Designation |
Associate Professor |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care, Gauhati Medical College, Bhangagarh, Guwahati
Kamrup
ASSAM
781032
India |
| Phone |
9706067392 |
| Fax |
|
| Email |
saikia.priyam80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyam Saikia |
| Designation |
Associate Professor |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care, Gauhati Medical College, Bhangagarh, Guwahati
Kamrup
ASSAM
781032
India |
| Phone |
9706067392 |
| Fax |
|
| Email |
saikia.priyam80@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical care, Gauhati Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Abhilekha Choudhury |
| Address |
Department of Anaesthesiology and Critical Care, Gauhati Medical College
College, Guwahati, Assam PIN- 781006 |
| 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 |
| DR ABHILEKHA CHOUDHURY |
Gauhati Medical College and Hospital |
Department of
Anaesthesiology and
Critical care
Kamrup
ASSAM |
9508465588
abhilekha18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, GAUHATI MEDICAL COLLEGE AND HOSPITAL |
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 |
Pericapsular Nerve Group block |
0.25% Ropivacaine 20ml to be administered via USG guidance to the musculofacial plane between the anterior psoas tendon and posterior pubic rami in 5 ml increments after negative aspiration and analgesia at rest will be assessed at every 5 minutes interval till 25 minutes |
| Intervention |
Suprainguinal Fascia Iliaca compartment block |
0.25% Ropivacaine 30 mL to be administered via USG guidance to suprainguinal fascia iliaca compartment in 5 mL increments after negative aspiration and analgesia at rest will be assessed at every 5 minutes interval till 25 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18-65 years
2. American Society of Anaesthesiologists (ASA) I and II
3. Patients posted for elective surgery for hip fracture under spinal anaesthesia
4. Availability of informed and written consent. |
|
| ExclusionCriteria |
| Details |
1. BMI more than 35kg per metre square
2. Known hypersensitivity to any of the drugs used in the study.
3. Patients not able to communicate properly or having hearing impairment
4. Patients with coagulopathy or on anticoagulation therapy.
5. Patient having infection at the site of block.
6. Pre-existing neurologic or anatomic deficits in the lower extremities
7. Patients on analgesic for chronic pain
8. Patients with untreated psychiatric illness, or using psychoactive substances
9. Prior surgery in the corresponding side of the inguinal or suprainguinal area |
|
|
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 |
| Comparison of analgesia measured with NRS during positioning for spinal anesthesia between patients receiving S-FICB and PENG block. |
After administering the block, analgesia at rest will be assessed at every 5 minutes interval and recorded on numeric pain rating scale, till 25 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparison of the ease of positioning for spinal anaesthesia measured with EOSP score between patients receiving S-FICB & PENG block.
2. Comparison of hemodynamic changes between the two groups
3. To evaluate Intra procedural complications with both the blocks |
EOSP score will be assessed 30 minutes after the block. Intra operative hemodynamic changes will be monitored at every 15 minutes interval till 60 minutes followed by every 30 minutes interval till the end of surgery. Intraprocedural complications if any to be specified |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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 4 |
|
Date of First Enrollment (India)
|
07/10/2024 |
| 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
|
Positioning the patient for Spinal Anaesthesia (SA) is extremely painful and requires higher doses of sedatives and opioids. Regional analgesic techniques offers better analgesia in positioning the patient for SA during treatment of hip fractures and fewer side effects than opioids, making it a safer choice. Very few studies on comparison of S–FICB to PENG block in terms of sitting position before SA has been done so far. Hence we plan a prospective randomized blinded study to assess the analgesic efficacy of ultrasound guided S - FICB and PENG Block for positioning patients before SA. |