| CTRI Number |
CTRI/2024/07/070616 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Preoperative Application Of Buprenorphine(Analgesic) Patch In Orthopedic Surgeries For Postoperative Pain Relief |
|
Scientific Title of Study
|
A Comparative Study to Evaluate Effect Of Preoperative Transdermal Buprenorphine Patch In Orthopedic Surgeries. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yash Patel |
| Designation |
Resident doctor |
| Affiliation |
GCS Medical College Hospital and Research Centre |
| Address |
Department Of Anaesthesia
GCS Medical College
hospital and research centre
near chamunda bridge
ahmedabad
Ahmadabad
GUJARAT
380025
India |
| Phone |
8866884734 |
| Fax |
|
| Email |
yashpatel05041999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Kheskani |
| Designation |
Associate Professor,department of anaesthesia |
| Affiliation |
GCS Medical College Hospital and Research Centre |
| Address |
Department Of Anaesthesia
GCS Medical College
hospital and research centre
near chamunda bridge
ahmedabad
Ahmadabad
GUJARAT
380025
India |
| Phone |
8866884734 |
| Fax |
|
| Email |
divya.kheskani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yash Patel |
| Designation |
Resident doctor |
| Affiliation |
GCS Medical College Hospital and Research Centre |
| Address |
Department Of Anaesthesia
GCS Medical College
hospital and research centre
near chamunda bridge
ahmedabad
Ahmadabad
GUJARAT
380025
India |
| Phone |
8866884734 |
| Fax |
|
| Email |
yashpatel05041999@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
GCS medical College Hospital and Research Centre |
| Address |
GCS medical College, Hospital and Research Centre, opp. DRM
office, Nr. Chamunda bridge, Naroda Road, Ahmedabad, Gujarat, India-380025 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Yash Patel |
GCS medical College, Hospital and Research Centre, |
Department of
anaesthesia Main ot
complex GCS medical
College, Hospital and
Research Centre, opp.
DRM office, Nr.
Chamunda bridge,
Naroda Road,
Ahmadabad
GUJARAT |
8866884734
yashpatel05041999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GCS Medical College,Hospital and Research Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
buprenorphine patch |
Dose-buprenorphine patch(10ug/hr)
Route-Transdermal
Duration-72hr postoperatively |
| Comparator Agent |
Group A (Patient Receiving Patch 12hr Before Surgery) And Group B(Patient Receiving Patch 24hr Before Surgery) |
buprenorphine patch same as intervention agent but comparison at different time of application preoperatively 12hr and 24hr |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA status 1,2 patient undergoing replacement surgeries
2.age group 20 to 70 years. |
|
| ExclusionCriteria |
| Details |
1.ASA Status 3,4
2.Patient with coagulopathy
3.patient with allergy to test drug/local anaesthetic
4.patient refusal
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare Efficacy of Transdermal Buprenorphine Patch when Applied 12hr and 24hr before surgery |
To compare Efficacy of Transdermal Buprenorphine Patch when Applied 12hr and 24hr before surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| any side effect assessment |
Preoperatively & postoperatively at 1,2,3,4,5,6,12,18,24,36,48,72hr post operatively |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/07/2024 |
| 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="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
postoperative pain is one of the major cause of morbidity in orthopedic surgeries which causes delay in ambulation and discharge so we will use buprenorphine patch in such patients preoperatively as it has delayed peak onset of action for postoperative pain relief.we will conduct this study in 60 patients.they will be divided in 2 groups randomly. in first group we will apply patch 12hr before surgery and in second group we will apply patch 24hr before surgery.then we will assess patient for onset of pain ,its severity,any side effect related to patch and compare both the groups. |