| CTRI Number |
CTRI/2019/03/017964 [Registered on: 07/03/2019] Trial Registered Prospectively |
| Last Modified On: |
03/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
comparative |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Trial to compare two blocks given in the thigh in patients with fracture femur( Long bone of the lower limb)to make it easy for the patients to sit for spinal anesthesia |
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Scientific Title of Study
|
Comparison of Preoperative Ultrasound guided Fascia iliaca block versus Femoral nerve block for proximal femur fractures before positioning for spinal anaesthesia – an observational study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meeta Gupta |
| Designation |
Post Graduate Student |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Anaesthesiology
Kasturba Medical College
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
91-6361214258 |
| Fax |
91-8242428183 |
| Email |
guptameeta2016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shaila S Kamath |
| Designation |
Professor & Head |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Anaesthesiology
Kasturba Medical College
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
91-9844090231 |
| Fax |
91-8242428183 |
| Email |
shaila.kamath@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Meeta Gupta |
| Designation |
Post Graduate Student |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Anaesthesiology
Kasturba Medical College
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
91-6361214258 |
| Fax |
91-8242428183 |
| Email |
guptameeta2016@gmail.com |
|
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Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Meeta Gupta |
| Address |
Department of Anaesthesiology
Kasturba Medical College
Mangalore
Manipal University
|
| Type of Sponsor |
Other [Principal investigator] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Meeta Gupta |
KMC Hospital ,Ambedkar Circle , Mangalore |
Department of Anaesthesiology
Kasturba Medical College
Mangalore
Manipal University
Dakshina Kannada
KARNATAKA |
91-6361214258
guptameeta2016@gmail.com |
| Meeta Gupta |
KMC Hospital ,Attavar, Mangalore |
Department of Anaesthesiology
Kasturba Medical College
Mangalore
Manipal University
Dakshina Kannada
KARNATAKA |
91-6361214258
guptameeta2016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, Kasturba Medical college ,Mangalore |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S728||Other fracture of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I, II ,III and Emergency patients.
Planned for proximal femur fracture fixation
|
|
| ExclusionCriteria |
| Details |
Patient’s refusal
History of allergy to local anaesthetics
Coagulopathy or Bleeding diathesis
H/o peripheral neuropathy
Previous femoral bypass surgery
Inguinal hernia
Local skin infection
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
level of pain relief by (VAS score) before positioning for spinal anaesthesia ( baseline,at 1,2,3,4,5,10and 15 minutes) between the two groups.
intraoperative hemodynamics ( Heart rate, Mean arterial pressure at 5,10 and 15 minutes) between the two groups. |
March 15,2019 to December 15,2019 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the duration of pain relief postoperatively (rescue analgesia) by VAS score at 2,4,8,12,16,20 and 24 hrs between the two groups.
To compare the total analgesic requirement in the next 24 hours between the two groups.
|
March 15, 2019 to December 15, 2019 |
|
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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)
|
11/03/2019 |
| 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
|
Reavley P, Montgomery AA, Smith JE, Binks S, Edwards J, Elder G, Benger J. Randomised trial of the fascia iliaca block versus the 3-in-1 block for femoral neck fractures in the emergency department. Emerg Med J. 2015 Sep; 32(9):685-9
Newman B, McCarthy L, Thomas PW, May P, Layzell M, Horn K. A comparison of pre-operative nerve stimulator-guided femoral nerve block and fascia iliaca compartment block in patients with a femoral neck fracture. Anaesthesia. 2013 Sep; 68(9):899-903
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This study is a comparative observational two centre trial, comparing the preoperative ultrasound guided fascia iliaca block versus femoral nerve block in proximal femur fractures before positioning for spinal anesthesia that will be conducted in two centres in India.The primary outcome measures will be level of pain relief by (VAS score) before positioning for spinal anesthesia ( baseline and at 1, 2, 3, 4 ,5, 10, and 15 minutes) and intraoperative hemodynamics ( heart rate and mean arterial pressure) at 5,10 and 15 minutes between the two groups. The secondary outcomes will be duration of pain relief postoperatively (rescue analgesia) by VAS score at 2,4,8,12,16,20 and 24 hours and total analgesic requirement between the two groups in the next 24 hours . |