| CTRI Number |
CTRI/2021/08/035857 [Registered on: 23/08/2021] Trial Registered Prospectively |
| Last Modified On: |
18/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Transdermal Buprenorphine and Diclofenac patch for post operative pain relief in patients undergoing major lower limb orthopaedic surgeries |
|
Scientific Title of Study
|
Comparison of effectiveness between Transdermal Buprenorphine and Diclofenac patch for post operative analgesia in major orthopaedic lower limb surgeries under spinal anaesthesia: prospective double blinded randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr PAMPANA BHUVAN CHANDRA KANTH |
| Designation |
1st year resident, MD Anaesthesia |
| Affiliation |
Government medical college, Bhavnagar |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, SIR T GENERAL HOSPITAL, BHAVNAGAR, GUJARAT-364001, INDIA
Bhavnagar
GUJARAT
364001
India |
| Phone |
8978908092 |
| Fax |
|
| Email |
bhuvanthedoc2805@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Komal SShah |
| Designation |
Associate Professor, Department of Anaesthesiology |
| Affiliation |
Government medical college, Bhavnagar |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, SIR T GENERAL HOSPITAL, BHAVNAGAR, GUJARAT-364001, INDIA
Bhavnagar
GUJARAT
364001
India |
| Phone |
9427215252 |
| Fax |
|
| Email |
shah.komal212@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PAMPANA BHUVAN CHANDRA KANTH |
| Designation |
1st year resident, MD Anaesthesia |
| Affiliation |
Government medical college, Bhavnagar |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, SIR T GENERAL HOSPITAL, BHAVNAGAR, GUJARAT-364001, INDIA
Bhavnagar
GUJARAT
364001
India |
| Phone |
8978908092 |
| Fax |
|
| Email |
bhuvanthedoc2805@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT MEDICAL COLLEGE,SIT T HOSPITAL, BHAVNAGAR |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
| Address |
GOVERNMENT MEDICAL COLLEGE , SIR T HOSPITAL, BHAVNAGAR, GUJARAT |
| 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 |
| PAMPANA BHUVAN CHANDRA KANTH |
SIR T GENERAL HOSPITAL, BHAVNAGAR |
DEPARTMENT OF ANAESTHESIOLOGY, SIR T GENERAL HOSPITAL, BHAVNAGAR, GUJARAT
Bhavnagar
GUJARAT |
8978908092
bhuvanthedoc2805@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE, BHAVNAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
TRANSDERMAL BUPRENORPHINE PATCH 5 MICROGRAMS |
TRANSDERMAL BUPRENORPHINE PATCH 5 MICROGRAMS GIVEN 30 MINUTES PRIOR TO SURGERY |
| Comparator Agent |
TRANSDERMAL DICLOFENAC PATCH 100 GRAMS |
TRANSDERMAL DICLOFENAC PATCH 100 GRAMS GIVEN 30 MINUTES PRIOR TO SURGERY |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Elective and emergency orthopaedic surgery patients with lower limb long bone fractures
2.Age group:18-60 years
3.ASA grade I- III
|
|
| ExclusionCriteria |
| Details |
1.Patients having injuries over other parts of body rather than lower limb
2.Altered coagulation profile and spinal deformities(Kyphosis, Scoliosis)
3.Suffering from respiratory disease, severe hepatic and renal dysfunction
4.Pregnant and lactating mother
5.Hypersensitivity to study drugs |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To compare the post-operative analgesia by visual analogue scale between both groups
2.To compare frequency of need for rescue analgesia between both groups
|
24 HOURS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare change in pulse rate, mean arterial pressure, Spo2, respiratory rate between both groups.
2.To compare the proportion of post-operative nausea, vomiting, PruritiS between both groups
|
24 HOURS |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
30/08/2021 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After taking approval from ethics committee, study will be initiated on patients fulfilling inclusion criteria, patients will be assessed for post operative pain according to VAS scale, need for rescue analgesia with in 24 hours of post operative period and side effects like nausea, vomiting and pruritis. |