| 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
|
|
|
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
|
|
|
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. |