| CTRI Number |
CTRI/2024/11/076315 [Registered on: 06/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Suprainguinal vs Infrainguinal fascia iliaca compartment block for pain relief for thigh bone surgery. |
|
Scientific Title of Study
|
EFFICACY OF SUPRAINGUINAL VS INFRAINGUINAL APPROACH OF FASCIA ILIACA COMPARTMENT BLOCK FOR TOTAL DURATION OF ANALGESIA IN FEMUR FRACTURE SURGERY:A RANDOMIZED DOUBLE BLIND CLINICAL 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 |
DIVYA GAJRA |
| Designation |
RESIDENT DOCTOR |
| Affiliation |
SSG HOSPITAL, GOVERMENT MEDICAL COLLEGE BARODA |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, NEW SURGICAL BLOCK, 2ND FLOOR,SSG HOSPITAL
VADODARA.
Vadodara
GUJARAT
390001
India |
| Phone |
9662897888 |
| Fax |
|
| Email |
divagajra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PINAL BUMIYA |
| Designation |
Assistant Professor |
| Affiliation |
SSG HOSPITAL GOVERMENT MEDICAL COLLEGE VADODARA |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, NEW SURGICAL BLOCK, 2ND FLOOR, SSG HOSPITAL VADODARA.
Vadodara
GUJARAT
390001
India |
| Phone |
8238037987 |
| Fax |
|
| Email |
drpinal09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DIVYA GAJRA |
| Designation |
RESIDENT DOCTOR |
| Affiliation |
SSG HOSPITAL GOVERMENT MEDICAL COLLEGE VADODARA. |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,NEW SURGICAL BLOCK.2ND FLOOR,VADODARA.
Vadodara
GUJARAT
390001
India |
| Phone |
9662897888 |
| Fax |
|
| Email |
divagajra@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY, SSG HOSPITAL,VADODARA. |
|
|
Primary Sponsor
|
| Name |
Government Medical College Baroda |
| Address |
Department of Anesthesiology, New Surgical Block,2nd Floor, SSG Hospital, Vadodara. |
| 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 Divya Gajra |
SSG HOSPITAL VADODARA |
Trauma Operation Theatre, 1st floor New Surgical Block SSG Hospital Vadodara
Vadodara
GUJARAT |
9662897888
divagajra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical and Health Research (IECHBR) Medical college ,SSG hospital Baroda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, (2) ICD-10 Condition: S729||Unspecified fracture of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
USG GUIDED INFRAINGUINAL FASCIA ILIACA COMPARTMENT BLOCK |
For USG guided infrainguinal fascia iliaca compartment block probe will be kept along inguinal crease and then glide inferiorly, identified femoral artery and femoral nerve. Needle will be inserted in-plane lateral to medial direction. After negative aspiration hydrodissection done to verify correct position of needle. Then total 30 ml of drug mixture of Inj. Bupivacaine (0.25%) given to complete the block. |
| Intervention |
USG GUIDED SUPRAINGUINAL FASCIA ILIACA COMPARTMENT BLOCK |
For USG guided SIFICB, the probe will be placed along the inguinal crease and then glide to inferiomedialy identified BOE-TIE sign formed by internal oblique muscle and sartorius muscle. Iliopsoas muscle and underneath fascia iliaca identified. Needle will be inserted in-plane caudal to cranial direction. After negative aspiration hydrodisection done to verify correct tip of needle. Then 30 ml of the drug mixture of Bupivacaine (0.25%) will be injected to complete the block. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing Fracture femur surgery under subarachnoid block & likely to have pain while positioning
2. Patients conformed to American Society of Anaesthesiologists (ASA) physical status I- III in preoperative assessment
3. Ability to follow the study protocol
3. Patient able to give written and informed consent.
4. Patient able to understand VAS regarding assessment of pain
|
|
| ExclusionCriteria |
| Details |
1. Patients with contraindication to subarachnoid block .
2. Patient with significant history of drug and alcohol abuse
3. Pre-existing lower extremity neuromuscular disorders
4. Patients with multiple fractures
5. Local infection over the injection site
6. Allergy or contraindications to the drugs used in the study ( local anaesthetics, NSAIDs, Steroid )
7. Patients with other severe comorbid conditions like Diabetes Mellitus, Hypertension, IHD, Bronchial asthma, COPD, neuromuscular and musculoskeletal disease
8. Chronic opioid use
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia using VAS score |
till 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Total number of rescue analgesics consumption in 48 hrs.
2. To assess ease of spinal positioning EOSP (EASE OF SPINAL POSITION SCORE)
3. Hemodynamic changes like pulse rate, systolic blood pressure, diastolic blood pressure, Oxygen saturation.
4. Complication- IF ANY |
BEFORE 20 MINUTES OF SPINAL ANAESTHESIA TO POST OPERATIVE 48 HOURS |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/11/2024 |
| 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 Yet Recruiting |
| 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
|
Our goal of study is to compare two different approaches of ultrasound guided regional block for total duration of analgesia in femur fracture surgery. 70 patients will be randomly divided into two group who are posted for femur fracture surgery under spinal anaesthesia in one group , ultrasound guided suprainguinal approach of fascia iliaca compartment block given 20 minutes before spinal anaesthesia pre operatively. In second group, ultrasound guided infrainguinal fascia iliaca compartment block given 20 minutes before spinal anaesthesia pre operatively Duration of analgesia will be assessed using VAS score till 48 hours as a primary outcome. As a secondary outcome, Total number of dose of rescue analgesia given in 48 hours post procedural, ease of positioning for spinal anaesthesia EOSP SCORE, vitals parameter at timely interval till 48 hours,and if any complication then noted.
|