| CTRI Number |
CTRI/2019/02/017417 [Registered on: 04/02/2019] Trial Registered Prospectively |
| Last Modified On: |
01/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare two different patches for pain relief after surgery of lower limb bone fracture |
|
Scientific Title of Study
|
A study to compare the safety and efficacy of two different strengths of transdermal buprenorphine for the treatment of post-operative pain following surgery for proximal femoral fracture |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anju Ghai |
| Designation |
Senior Professor |
| Affiliation |
PGIMS Rohtak, Haryana |
| Address |
Surgery operation theatre, Department of Anaesthesiology, PGIMS Rohtak
Medical campus, PGIMS Rohtak, Haryana-124001
Rohtak
HARYANA
124001
India |
| Phone |
9416974794 |
| Fax |
|
| Email |
dranjughai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anju Ghai |
| Designation |
Senior Professor |
| Affiliation |
PGIMS Rohtak, Haryana |
| Address |
Surgery operation theatre, Department of Anaesthesiology, PGIMS Rohtak
Medical campus, PGIMS Rohtak, Haryana-124001
Rohtak
HARYANA
124001
India |
| Phone |
9416974794 |
| Fax |
|
| Email |
dranjughai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya Gupta |
| Designation |
Junior Resident |
| Affiliation |
PGIMS Rohtak, Haryana |
| Address |
Surgery operation theatre, Department of Anesthesia, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9992996985 |
| Fax |
|
| Email |
priyagupta0905@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of anaesthesiology Pt B D Sharma PGIMS Rohtak |
| Address |
Pt B D Sharma PGIMS Rohtak |
| 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 Priya Gupta |
Department of Anaesthesia |
Pt B D Sharma PGIMS Rohtak
Rohtak
HARYANA |
9992996985
priyagupta0905@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 |
(1) ICD-10 Condition: V899||Person injured in unspecified vehicle accident, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Transdermal buprenorphine |
Using transdermal buprenorphine for post operative pain relief in patients operated for proximal femoral fractures |
| Comparator Agent |
Transdermal buprenorphine of two different strengths : 5mg and 10mg |
studying the safety and efficacy of two different strengths of transdermal buprenorphine in post operative pain relief |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Total no. of patients- 75
ASA- I to III
Patients undergoing surgery for proximal femoral fractures under spinal anesthesia |
|
| ExclusionCriteria |
| Details |
Patients having poly trauma with any other fracture, Obese, hepatic or renal impairment, myasthenia gravis, delirium tremens, skin allergy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual analogue scale (VAS)
Post operative nausea and vomiting(PONV)
Rescue analgesia
Complications |
Visual analogue scale (VAS) at 2 hrs,4 hrs,6 hrs,12 hrs,24 hrs,3rd day,5th day,7th day
Post operative nausea and vomiting(PONV) at 2 hrs,4 hrs,6 hrs 12 hrs,24 hrs,3rd day, 5th day 7th day
Rescue analgesia at 1st,2nd,3rd,4th,5th,6th,7th day
Complications at 1st,2nd,3rd,4th,5th,6th,7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Heart rate
Mean arterial pressure
SpO2 |
Baseline, 15min, 30min, 1st hr, 2nd hr, 3rd hr, at the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/02/2019 |
| Date of Study Completion (India) |
31/01/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/01/2019 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
I am conducting a study to compare the safety and efficacy of two different strengths of transdermal buprenorphine for the treatment of post-operative pain following surgery for proximal femoral fracture. |