| CTRI Number |
CTRI/2021/02/031209 [Registered on: 11/02/2021] Trial Registered Prospectively |
| Last Modified On: |
10/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparing two approaches of a nerve block for post operative pain after hip surgeries |
|
Scientific Title of Study
|
A Comparative study of infrainguinal versus suprainguinal approach of Fascia iliaca compartment block for postoperative analgesia in Hip surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sangeeth S |
| Designation |
Junior Resident, Department of Anaesthesia |
| Affiliation |
TEERTHANKER MAHAVIR MEDICAL COLLEGE AND RESEARCH CENTRE |
| Address |
AMRTH
NEAR PARK JUNCTION
DHANUVACHAPURAM
DHANUVACHAPURAM P.O
THIRUVANANTHAPURAM
KERALA
DR.SANGEETH.S
DEPATMENT OF ANAESTHESIA
TEERTHANKER MAHAVIR UNIVERSITY
BAGADPUR
DELHI ROAD
MORADABAD
UTTARPRADESH
244001
Thiruvananthapuram
KERALA
695503
India |
| Phone |
9495671793 |
| Fax |
|
| Email |
dr.sangeethsureshkumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pallavi Ahluwalia |
| Designation |
PROFESSOR, DEPARTMENT OF ANAESTHESIA |
| Affiliation |
TEERTHANKER MAHAVIR MEDICAL COLLEGE AND RESEARCH CENTRE |
| Address |
DEPARTMENT OF ANAESTHESIA
TEERTHANKER MAHAVIR MEDICAL COLLEGE AND RESEARCH CENTRE
BAGADPUR
DELHI ROAD
MORADABAD
UTTARPRADESHHESIA,
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7599111465 |
| Fax |
|
| Email |
drpallaviahluwalia@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
SANGEETHS |
| Designation |
JUNIOR RESIDENT, DEPARTMENT OF ANAESTHESIA |
| Affiliation |
TEERTHANKER MAHAVIR MEDICAL COLLEGE AND RESEARCH CENTRE |
| Address |
DR.SANGEETH.S
DEPATMENT OF ANAESTHESIA
TEERTHANKER MAHAVIR MEDICAL COLLEGE AND RESEARCH CENTRE
BAGADPUR
DELHI ROAD
MORADABAD
UTTARPRADESH
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9495671793 |
| Fax |
|
| Email |
dr.sangeethsureshkumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| TEERTHANKER MAHAVIR MEDICAL COLLEGE AND RESEARCH CENTRE |
|
|
Primary Sponsor
|
| Name |
TMMC |
| Address |
BAGARPUR,NH 24,MORADABAD. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sangeeth S |
TEERTHANKER MAHAVIR MEDICAL COLLEGE AND RESEARCH CENTRE |
Department of Anaesthesia
Bagadpur
NH24
Moradabad
244001
Moradabad
UTTAR PRADESH |
9495671793
dr.sangeethsureshkumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONALETHICSCOMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S720||Fracture of head and neck of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Suprainguinal Facia iliaca compartment block |
30ml of 0.25% bupivacaine is injected into fascia iliaca compartment suprainguinally by 2 POP technique. And postoperative pain is assessed for 24 hours |
| Intervention |
infrainguinal FASCIA ILIACA COMPARTMENT BLOCK |
30ml of 0.25% bupivacaine is injected into fascia iliaca compartment infrainguinally by 2 POP technique. And postoperative pain is assessed for 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age – 18 to 60 years
Gender – both male and female
Patients listed for elective surgery under lumbar subarachnoid block
Elective surgeries lasting 90-120 mins.
Hip surgeries - Total hip replacement
Hemi arthroplasty- Unipolar and Bipolar
Proximal femoral nailing
Dynamic hip screw
Core decompression
|
|
| ExclusionCriteria |
| Details |
ASA grade 3 or more
Patients on chronic analgesic therapy.
Allergy to local anesthetic
Infection at the block site.
Neurological deficit in lower limbs.
Contraindication to subarachnoid block (SAB).
Inability to comprehend visual analogue scale (VAS) score
Neuro muscular disorders
Patient requiring conversion to GA
Prolonged surgeries
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the post operative analgesia period of suprainguinal approachof FICB and infrainguinal approach of FICB
|
To compare postoperative analgesia of both suprainguinal and infrainguinal approach of FICB
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters,HR,MAP,Time of first resque analgesia,side effects if any |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/02/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
•The Fascia Iliaca Compartment Block (FICB) has been used for perioperative analgesia in patients undergoing hip surgeries(1). •The FICB has a higher rate of block of the femoral and lateral femoral cutaneous nerve than perivascular femoral nerve block (2). • In the literature there are two techniques of Fascia Iliaca Compartment Block (FICB) administration has been described, a conventional infrainguinal approach by Dalens (1) and a modified suprainguinal approach by Stevens (3). • •But, despite its higher spread, there has been no clinical randomized trial published in the literature, showing the superiority among modified suprainguinal approach of FICB to infrainguinal for postoperative pain relief in hip surgeries(4,5). •We therefore undertake this prospective randomized trial to evaluate which technique among FICB confers more postoperative analgesic benefit in patients undergoing hip surgeries. |