| CTRI Number |
CTRI/2018/01/011464 [Registered on: 22/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
16/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of Levobupivacaine versus Bupivacaine in Fascia Iliaca Compartment Block (FICB) [A type of anaesthesia] for Postoperative Pain Management in Surgeries for Hip Fractures |
|
Scientific Title of Study
|
Comparison of Levobupivacaine versus Bupivacaine in Fascia Iliaca Compartment Block (FICB) for Postoperative Pain Management in Surgeries for Fractures of Neck of Femur
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lalit Kumar Raiger |
| Designation |
Senior Professor |
| Affiliation |
R.N.T. Medical College |
| Address |
Department of Anesthesia, R.N.T. Medical College
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414352823 |
| Fax |
|
| Email |
drlalitkumar@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lalit Kumar Raiger |
| Designation |
Senior Professor |
| Affiliation |
R.N.T. Medical College |
| Address |
Department of Anesthesia, R.N.T. Medical College
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414352823 |
| Fax |
|
| Email |
drlalitkumar@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sneha Arun Betkekar |
| Designation |
Junior Resident |
| Affiliation |
R.N.T. Medical College |
| Address |
Department of Anesthesia, R.N.T. Medical College
Udaipur
RAJASTHAN
313001
India |
| Phone |
9983833966 |
| Fax |
|
| Email |
snehabetkekar@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia, R.N.T. Medical College and Maharana Bhupal Government Hospital, Chetak Circle, Udaipur, Rajasthan 313001 |
|
|
Primary Sponsor
|
| Name |
Maharana Bhupal Government Hospital |
| Address |
R.N.T. Medical College, Udaipur |
| Type of Sponsor |
Government 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 Lalit Kumar Raiger |
Orthopaedic Operation Theatre |
Department of Anesthesia, R.N.T. Medical College
Udaipur
RAJASTHAN |
9414352823
drlalitkumar@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Extracapsular fractures of proximal femur , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine |
Bupivacaine 0.25% 30 ml in Fascia iliaca compartment block |
| Intervention |
Levobupivacaine |
Levobupivacaine 0.25% 30 ml in Fascia iliaca compartment block |
| Comparator Agent |
Placebo |
Needle inserted and removed without injection of drug in location of Fascia iliac compartment block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female patients >17 years undergoing elective surgery for fractures of extracapsular neck of femur |
|
| ExclusionCriteria |
| Details |
Patient refusal, Coagulopathy, Infection at puncture site, Local anaesthetic allergy, Uncooperative patient |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS at 24 hrs |
24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to first analgesic request |
24 hrs |
| Total analgesic consumption |
24 hrs |
| Time to sensory Onset |
30 mins |
| Reversal of sensory block |
24 hrs |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/03/2016 |
| Date of Study Completion (India) |
31/03/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomised, prospective, double blind, placebo controlled study to compare levobupivacaine and bupivacaine in equal concentrations and volume in the Fascia iliaca compartment block for postoperative pain management in patients undergoing surgery for extracapsular fractures of the neck of femur. The primary outcomes measured are the VAS at 24hrs and secondary outcomes are the time to first analgesic request and total analgesic consumption over 24hrs. |