| CTRI Number |
CTRI/2023/07/054643 [Registered on: 03/07/2023] Trial Registered Prospectively |
| Last Modified On: |
15/06/2024 |
| 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
|
Comparing effect of sonography guided supra-inguinal fascia iliaca compartment block versus femoral nerve block for pain relief before spinal anaesthesia in hip fracture patients. |
|
Scientific Title of Study
|
Comparing effect of ultrasound guided supra-inguinal fascia iliaca compartment block versus femoral nerve block for analgesia of positioning pain during spinal anaesthesia in hip fracture patients: A prospective randomized double blind study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BHMEC/DNB/21/2022 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lipsa priyadarshini |
| Designation |
DNB trainee |
| Affiliation |
BHABHA ATOMIC RESEARCH CENTRE HOSPITAL |
| Address |
MAIN OPERATION THEATRE
ROOM 1
DEPARTMENT OF ANAESTHESIA
BHABHA ATOMIC RESEARCH CENTRE HOSPITAL,ANUSHAKTINAGAR,MUMBAI ,MAHARASHTRA ,INDIA
Room no -17, RMO quarters
Bhabha atomic research centre hospital
Anushaktinagar
Mumbai
400094
Maharashtra
PIN 400094
Mumbai
MAHARASHTRA
400094
India |
| Phone |
9438544883 |
| Fax |
|
| Email |
lipsa.8112@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jalpa Kate |
| Designation |
Consultant anaesthesia |
| Affiliation |
BHABHA ATOMIC RESEARCH CENTRE HOSPITAL |
| Address |
MAIN OPERATION THEATRE,
ROOM NO 1
DEPARTMENT OF ANAESTHESIA
BHABHA ATOMIC RESEARCH CENTRE HOSPITAL,ANUSHAKTINAGAR,MUMBAI ,MAHARASHTRA ,INDIA
ROOM NO 1, DEPARTMENT OF ANAESTHESIA , ANAESTHESIA OPD ANUSHAKTINAGAR, MUMBAI, MAHARASHTRA
PIN 400094
Mumbai
MAHARASHTRA
400094
India |
| Phone |
9820655883 |
| Fax |
|
| Email |
jakate@barc.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Jalpa Kate |
| Designation |
Consultant anaesthesia |
| Affiliation |
BHABHA ATOMIC RESEARCH CENTRE HOSPITAL |
| Address |
MAIN OPERATION THEATRE,
BHABHA ATOMIC RESEARCH CENTRE HOSPITAL,ANUSHAKTINAGAR,MUMBAI ,MAHARASHTRA ,INDIA
ANUSHAKTINAGAR, MUMBAI, MAHARASHTRA
PIN 400094
Mumbai
MAHARASHTRA
400094
India |
| Phone |
9820655883 |
| Fax |
|
| Email |
jakate@barc.gov.in |
|
|
Source of Monetary or Material Support
|
| HEAD OF MEDICAL DIVISION ,DISIONAL ADMINISTRATIVE OFFICE , BHABHA ATOMIC RESEARCH CENTRE HOSPITAL
ANUSHAKTINAGAR , MUMBAI , MAHARASHTRA
PIN - 400094 |
|
|
Primary Sponsor
|
| Name |
BHABHA ATOMIC RESEARCH CENTRE HOSPITAL |
| Address |
Anushaktinagar
Mumbai
PIN 400094 |
| Type of Sponsor |
Other [Central Government 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 |
| Lipsa Priyadarshini |
Bhabha atomic research centre hospital |
Main operation theatre Room no 1,Bhabha atomic research centre Hospital,Anushaktinagar
Mumbai
PIN 400094
Mumbai
MAHARASHTRA |
9438544883
lipsa.8112@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical ethics committee Bhabha atomic research centre hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Femoral nerve block |
Block will be performed under ultrasound guidance using linear probe placed transversely on femoral crease to identify femoral artery, vein and nerve. Under local anaesthesia, 22G needle will be introduced and 30 cc local anaesthetic mixture will be injected to near femoral nerve. Post block pain score will be noted in 5 minutes interval till 20 minutes before positioning for spinal anesthesia |
| Intervention |
Supra-inguional fascia iliaca compartment block |
Block will be performed under ultrasound guidance using 90 mm needle. Needle will be introduced 1cm cephalad to the inguinal ligament to place the needle tip in the space between the fascia iliaca and iliacus muscle. 30cc local anaesthetic mixture will be injected after confirmation of drug spread between iliacus and psoas major muscle . post block pain score will be noted in 5 minutes interval till 20 minutes before positioning for spinal anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients (Age >18 years) of ASA Class I, II and willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Local skin infection, Patients with difficulty to express pain scores,Neuropsychiatric disorders ,Pregnant patients.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare analgesia between S-FICB & FNB using numerical rating scale at the time of spinal anaesthesia positioning. |
Every 5 mins till total 20 mins of administering block & at the time of positioning for spinal anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the time taken for administration of either block
To compare the duration of postoperative analgesia with S-FICB & FNB
|
Time taken for block administration & postoperatively NRS assessment till NRS increases to more than 4 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2023 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
We will be conducting a prospective randomized comparative study to evaluate the efficacy of ultrasound guided supra-inguinal fascia iliaca compartment block(S-FICB) and femoral nerve block(FNB) for analgesia of positioning pain during spinal anaesthesia for hip fracture surgery at BARC hospital. USG guided S-FICB or FNB will be given before spinal anaesthesia positioning and pain score at that time will be noted along with time taken for performance of either block and post operative duration of analgesia. Numerical Rating Scale (NRS) will be used for evaluating severity of pain. |