| CTRI Number |
CTRI/2021/03/031677 [Registered on: 03/03/2021] Trial Registered Prospectively |
| Last Modified On: |
02/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare the efficacy of IV fentanyl versus femoral nerve block for positioning prior to subarachnoid block in patients undergoing fracture femur surgeries. |
|
Scientific Title of Study
|
A prospective comparative study on efficacy of IV fentanyl versus femoral nerve block for positioning prior to subarachnoid block in patients undergoing fracture femur surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Thanuja N Umesh |
| Designation |
Post graduate medical student |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Bangalore Medical College and Research Institute, Krishna Rajendra road, Bengaluru
Department of Anaesthesiology, Bangalore Medical College and Research Institute, Krishna Rajendra road, Bengaluru, Karnataka
Bangalore
KARNATAKA
560002
India |
| Phone |
9686754702 |
| Fax |
|
| Email |
thanujaumesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soumya Rohit |
| Designation |
Assistant professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Bangalore Medical College and Research Institute, Krishna Rajendra road, Bengaluru
Department of Anaesthesiology, Bangalore Medical College and Research Institute, Krishna Rajendra road, Bengaluru, Karnataka
Bangalore
KARNATAKA
560002
India |
| Phone |
9611106641 |
| Fax |
|
| Email |
dr.soumyarohit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soumya Rohit |
| Designation |
Assistant professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Bangalore Medical College and Research Institute, Krishna Rajendra road, Bengaluru
Department of Anaesthesiology, Bangalore Medical College and Research Institute, Krishna Rajendra road, Bengaluru, Karnataka
Bangalore
KARNATAKA
560002
India |
| Phone |
9611106641 |
| Fax |
|
| Email |
dr.soumyarohit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Medical College and Research Institute, Krishna Rajendra road, Bengaluru-560002, Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Thanuja N Umesh |
| Address |
Department of Anaesthesiology, Bangalore Medical College and Research Institute, Krishna Rajendra road, Bengaluru, Karnataka,pin-560002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DrSoumya Rohit |
Department of Anaesthesiology, Bangalore Medical College and Research Institute, Krishna Rajendra road, Bengaluru, Karnataka,pin-560002 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrThanuja N Umesh |
Bangalore Medical College and Research Institute |
Department of Anaesthesiology, Bangalore Medical College and Research Institute, Krishna Rajendra road, Bengaluru, Karnataka,pin-560002
Bangalore
KARNATAKA |
9686754702
thanujaumesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BMCRI ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S729||Unspecified fracture of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Femoral nerve block |
Femoral nerve block with 0.2% ropivacaine 15 ml prior to subarachnoid block in patients undergoing fracture femur surgeries |
| Comparator Agent |
IV fentanyl |
1mcg/kg IV fentanyl prior to subarachnoid block in patients undergoing fracture femur surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients(18 – 65yrs) of both genders will be included after receiving informed written consent
2. Patients belonging to American Society of Anesthesiologist class 1&2
3. Patients with painful femoral fractures planned for open reduction and internal fixation.
|
|
| ExclusionCriteria |
| Details |
1. Patient does not have pain
2. Patient refusing to participate in study
3. Patient with allergy to local anaesthetics
4. Patient with peripheral neuropathy, bleeding diathesis, previous femoral bypass surgery, inguinal hernia, inflammation or infection over injection site, morbid obesity, spine abnormality.
5. Patient with psychiatric disorders and poly trauma / communited fractures.
6. Use of analgesics for premedication.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Preoperative pain relief and patient comfort before shifting into OT and while positioning for spinal anesthesia |
Preoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of sensory and motor block |
Intra and post operative period |
| Time for requirement of first rescue analgesia |
Post operative period |
| VAS score assessed at 0hr, 4hr, 8hr, 12hr, 24hr |
Post operative period |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
02/02/2021 |
| 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="0"
Months="3"
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)?
Response - NO
|
|
Brief Summary
|
This is a prospective randomised clinical study comparing the efficacy of 1mcg/kg IV fentanyl versus femoral nerve block with 0.2% ropivacaine 15ml for positioning prior to subarachnoid block in patients undergoing fracture femur surgeries. It will be conducted in a total of 70 patients, 35 in each group, in all the hospitals attached to Bangalore Medical College and Research Institute. The primary outcome is to compare preoperative pain relief and patient comfort before shifting into OT and while positioning for spinal anesthesia. Secondary outcome is to observe other effects of femoral nerve blockade when used in combination with regional anesthesia techniques in first 24 hours. |