| CTRI Number |
CTRI/2024/12/077883 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARATIVE EVALUATION OF ANALGESIC EFFICACY OF TRANSDERMAL BUPRENORPHEN PATCH VERSUS TRANSDERMAL DICLOFENAC PATCH AS POSTOPERATIVE PAIN MANAGEMENT IN LOWER LIMB SURGERIES : A PROSPECTIVE, COMPARATIVE, CLINICAL STUDY. |
|
Scientific Title of Study
|
Comparative Evaluation of Analgesic
Efficacy of Transdermal Buprenorphen Patch versus Transdermal Diclofenac
Patch as Postoperative Pain Management in Lower Limb Surgeries: A
Prospective, Comparative, Clinical Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jagrati Thadani |
| Designation |
Resident Doctor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex ,1st Floor, Dhiraj
Hospital , Smt.Bhikiben Kanjibhai Shah Medical Institute and
Research Centre , Wagodhiya, Piparia , Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
07575070391 |
| Fax |
|
| Email |
drjagratithadani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amit Chauhan |
| Designation |
Professor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex ,1st Floor, Dhiraj
Hospital , Smt.Bhikiben Kanjibhai Shah Medical Institute and
Research Centre , Wagodhiya, Piparia , Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9426368170 |
| Fax |
|
| Email |
dramitchauhan85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jagrati Thadani |
| Designation |
Resident Doctor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex ,1st Floor, Dhiraj Hospital , Smt.Bhikiben Kanjibhai Shah Medical Institute and
Research Centre , Wagodhiya, Piparia , Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
09426368170 |
| Fax |
|
| Email |
drjagratithadani@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Wagodhia , Pipariya, Vadodara, Gujarat , India Pincode- 391760 |
| Type of Sponsor |
Private 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 Jagrati Thadani |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
Anaesthesia Department, General Ot Complex ,1st Floor, Dhiraj
Hospital , Smt.Bhikiben Kanjibhai Shah Medical Institute and
Research Centre , Wagodhiya, Piparia , Vadodara
Vadodara
GUJARAT |
7575070391
drjagratithadani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SUMANDEEP VIDYAPEETH INSTITUTIONAL ETHICS COMMITEE |
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 |
transdermal buprenorphine patch is applied at the end of lower limb surgery and post operatively vas score is checked, when vas is equal to or more than 4 inj. tramadol 50mgi.v is given as
rescue analgesia.
postoperatively vas is analyzed every 4 hourly for 24 hours, to compare topup analgesia requirement. |
| Comparator Agent |
transdermal diclofenac patch |
transdermal diclofenac patch is applied at the end of lower limb surgery and post operatively vas score is checked, when vas is equal to or more than 4 inj. tramadol 50mgi.v is given as
rescue analgesia.
postoperatively vas is analyzed every 4 hourly for 24 hours, to compare topup analgesia requirement. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to sign the written & informed consent.
Age group: 18-70 years
Patients posted for major lower limb orthopedic surgeries under subarachnoid block with ASA-1 or ASA-2 grade
|
|
| ExclusionCriteria |
| Details |
Patient’s refusal from taking part in the study.
Special populations
Pregnant and lactating women
History of allergy to drugs
Severe kidney and liver disease
Patients with neuropathies or nerve injuries
Patients with pain due to cause other than presenting disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare efficacy of transdermal buprenorphine patch vs transdermal diclofenac patch. |
Baseline
While shifting the patient
at 2hours
at 4 hours
at 6hours
at 8 hours
at 12 hours
at 16 hours
at 20 hours
at 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare rescue analgesia for transdermal diclofenac patch vas transdermal buprenorphine patch |
Baseline
While shifting the patient
at 2hours
at 4 hours
at 6hours
at 8 hours
at 12 hours
at 16 hours
at 20 hours
at 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)
|
20/12/2024 |
| 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="6"
Days="0" |
|
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
|
the purpose of this study is to compare the efficacy and safety profile of transdermal diclofenac patch vs transdermal buprenorphine patch in postoperative pain management in patients undergoing elective lower limb surgery under spinal anaesthesia |