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CTRI Number  CTRI/2016/09/007316 [Registered on: 28/09/2016] Trial Registered Prospectively
Last Modified On: 27/09/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   ultrasound guided injection of medicine around nerves for pain relief in patients with femoral fractures  
Scientific Title of Study   Comparative evaluation of ultrasound guided femoral nerve block versus fascia iliaca block for positioning during central neuraxial anesthesia in patients with proximal femoral fractures 
Trial Acronym  FNBFIB 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M Manjuladevi 
Designation  Associate Professor 
Affiliation  St johns medical college and hospital 
Address  Department of Anesthesia and Critical care St johns medical college and hospital, kormangala, bengaluru,
Department of Anesthesia and Critical care St johns medical college and hospital, kormangala
Bangalore
KARNATAKA
560034
India 
Phone  09449059395  
Fax    
Email  drmanjula95@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bindu George 
Designation  Additional Professor 
Affiliation  St johns medical college and hospital 
Address  Department of Anesthesia and Critical care St johns medical college and hospital, kormangala, bengaluru,
Department of Anesthesia and Critical care St johns medical college and hospital, kormangala, bengaluru,
Bangalore
KARNATAKA
560034
India 
Phone  09342552324  
Fax    
Email  bindu575@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jayanthi Savio 
Designation  Member Secretary 
Affiliation  St johns medical college and hospital 
Address  IEC St johns medical college and hospital, kormangala, bengaluru,
IEC St johns medical college and hospital, kormangala, bengaluru,
Bangalore
KARNATAKA
560034
India 
Phone  08022066346  
Fax    
Email  jayanthisjmc@gmail.com  
 
Source of Monetary or Material Support  
St Johns medical college and hospital, Bengaluru, Karnataka 560034 
 
Primary Sponsor  
Name  St Johns Medical College  
Address  Department of Anesthesia and Critical Care St johns medical college and hospital Kormanagala, bengaluru, Karnataka 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bindu George  st johns medical college and hospital  Department of Anesthesia and Critical care, 2nd floor St johns medical college and hospital, kormangala, bengaluru,
Bangalore
KARNATAKA 
9342552324

bindu575@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients with femoral fracture posted for surgery under spinal anesthesia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  ultrasound guided fascia iliacus block   fascia iliacus block given for ease of positioning for spinal anesthesia, in patients posted for surgery with femoral fractures.  
Intervention  ultrasound guided femoral nerve block  femoral nerve block given for ease of positioning for spinal anesthesia, in patients posted for surgery with femoral fractures  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All patients with proximal femoral fractures undergoing surgery under central neuraxial anesthesia.

Age 18 to 80 years.
 
 
ExclusionCriteria 
Details  1)Patients with coagulopathies
2)Patients allergic to local anesthetics
3) Mentally challenged patients.
4) Obese patients
5)Poly trauma patients.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
PRIMARY OBJECTIVE: To compare the efficacy of analgesia provided by ultrasound guided femoral nerve block versus fascia iliaca block in facilitating positioning for central neuraxial procedure in patients with proximal femoral fractures.

 
a) prior to spinal administartion
b) postoperative period for 4 hours
 
 
Secondary Outcome  
Outcome  TimePoints 
SECONDARY OBJECTIVE: - To evaluate analgesics requirement in 24hrs postoperatively in both groups.
 
follow up for 24hrs 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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)   03/10/2016 
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   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Fracture femur is a common orthopedic problem following trauma in all age groups and central neuraxial blocks such as spinal / epidural is the preferred technique for providing anaesthesia. Correct positioning during central neuraxial anesthesia  is a prerequisite for successful procedure. However limb immobility and extreme pain are the deterrents for an ideal positioning. Various modalities like femoral nerve block, fascia iliaca block systemic opioids and non opioids, have been advocated to provide analgesia and improve positioning in these patients.

Femoral nerve block and fascia iliaca block are proposed to provide analgesia and improve positioning in patients with femoral fractures. Conflicting results are available in the literature, there is no study comparing efficacy of ultrasound guided femoral block and fascia iliaca block. We decided to conduct this study with the aim to compare the benefits of block prior to  positioning for central neuraxial procedure in patients undergoing surgery for fracture femur.

Methodology : Approval from institutional ethical committee will be obtained. All patients with proximal femoral fractures undergoing surgery under central neuraxial anesthesia will be enrolled for the study. A detailed pre-anaesthetic checkup will be carried out in each patient. The patient will be given Pantoprazole 40mg on the morning of surgery. Patient will be kept nil per orally from 10pm previous night of surgery. On arrival to Operation theatre, standard monitors including ECG, Pulse oximeter, and non invasive blood pressure will be attached and baseline vital parameters will be recorded. Intravenous access will be secured with 18 G IV cannula and  GROUP1: Patients will receive ultrasound guided femoral nerve block with 15ml of equal mixture of 0.5% bupivacaine and 2% xylocaine with adrenaline. GROUP 2: patients will receive fascia iliaca block with 15ml of equal mixture of 0.5% bupivacaine and 2% xylocaine with adrenaline. Central neuroaxial anesthesia will be performed in these patients after 15 minutes of giving block, patient comfort for positioning, and quality of positioning for performing central neuraxial procedure will be assessed by ease of insertion.

Patients will be monitored for 24 hours for the postoperative analgesia . Data will be collected in a study proforma for each patient. and will be later analyzed statistically.

 
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