| CTRI Number |
CTRI/2025/08/092972 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive
Other (Specify) [transdermal patch] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Testing two pain relief patches for better recovery after lower limb bone surgeries |
|
Scientific Title of Study
|
Efficacy of Buprenorphine and Fentanyl transdermal patches in managing postoperative pain following lower limb orthopaedic surgeries - A double blinded randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lokeshwar V |
| Designation |
Senior resident |
| Affiliation |
Sri Lalithambigai Medical College and Hospital |
| Address |
Ground Floor OT Complex, Sri Lalithambigai edical College and Hospital,Adayalampattu, Maduravoyal
Chennai
TAMIL NADU
6000955
India |
| Phone |
9884332066 |
| Fax |
|
| Email |
lokeshwarvijayakumaar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prasanna Kumar |
| Designation |
Assisstant Professor |
| Affiliation |
Sri Lalithambigai medical college and Hospital |
| Address |
Ground Floor OT Complex, Sri Lalithambigai medical College and Hospital,Adayalampattu, Maduravoyal
Chennai
TAMIL NADU
600095
India |
| Phone |
9751898045 |
| Fax |
|
| Email |
prasan1092@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prasanna Kumar |
| Designation |
Assisstant Professor |
| Affiliation |
Sri Lalithambigai medical college and Hospital |
| Address |
Ground Floor OT Complex, Sri Lalithambigai medical College and Hospital,Adayalampattu, Maduravoyal
Chennai
TAMIL NADU
600095
India |
| Phone |
9751898045 |
| Fax |
|
| Email |
prasan1092@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Lalithambigai Medical College and Hospital,Adayalampattu, Maduravoyal, Chennai 600095, India |
|
|
Primary Sponsor
|
| Name |
Lokeshwar Vijayakumar |
| Address |
38/41, Periathambi street, Choolai, Chennai – 600112
Cell – 9884332066 |
| Type of Sponsor |
Other [self] |
|
|
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 Lokeshwar Vijayakumar |
Sri Lalithambigai Medical College and Hospital |
A012, Ground Floor, OT complex, Sri Lalithambigai Medical College and Hospital, adayalampattu, maduravoyal, chennai
Chennai
TAMIL NADU |
9884332066
lokeshwarvijayakumaar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Sri Lalithambigai Medical College and Hospital, Faculty of medicine, Dr MGR Educational and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M848||Other disorders of continuity of bone, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Buprenorphine transdermal patch 10 mcg/hour |
Comparing pain relief satisfaction using buprenorphine transdermal patch through VAS score, Ramsay sedation score, time for rescue analgesia and their adverse effects |
| Comparator Agent |
Fentanyl transdermal patch 25 mcg/ hour |
Comparing pain relief using fentanyl transdermal patch satisfaction through VAS score, Ramsay sedation score, time for rescue analgesia and their adverse effects |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA 1 and 2 patients
2. Patients with BMI of more than 25
3. Patients scheduled for elective lower lib surgeries and who have given consent for the study
4. Age group 18 to 65 years
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1. ASA physical status of more than 3
2. Patients posted for emergency surgeries
3. Patients with history of allergy to study drugs
4. Pregnant and lactating woman
5. Patients with impaired pulmonary function
6. Patients with opioid intolerance
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Postoperative Pain Level
Measurement Method: Visual Analog Scale (VAS), scored from 1 (no pain) to 10 (severe pain).
|
Post surgery
6 hours
12 hours
24 hours
48 hours
72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2. Sedation Levels
Measurement Method: Ramsay Sedation Score (scale: 1 to 5).
3. Time to Rescue Analgesia
Time in hours until the first dose of rescue analgesia (diclofenac 75 mg IV).
4. Adverse Effects
Observation of opioid-related side effects (e.g., nausea, vomiting, pruritus).
|
Post surgery
6 hours
12 hours
24 hours
48 hours
72 hours |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/08/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a comparative evaluation of buprenorphine (10 µg/h) and fentanyl (25 µg/h) transdermal patches in the context of lower limb orthopedic surgeries in patients with BMI of more than 25. This study aims to assess the analgesic efficacy of these patches, alongside noting hemodynamic variability and potential adverse effects, to establish optimized pain management strategies for patients undergoing lower limb orthopaedic procedures.Preoperative phase
- Patient screening :
Eligible patients will
be identified based on the inclusion and exclusion criteria
Written informed consent
will be obtained from all participants
- Baseline data collection :
Demographic details (
Age, gender, weight, BMI)
Preop pain assessment
and medical history
Details of the planned
surgical procedure Intraoperative phase
- Standardized anaesthetic
protocol :
All patients will
receive the same anaesthesia regimen to minimise variability in postoperative
pain outcomes.
Duration and type of
surgery will be recorded.
- Application
of Transdermal patches will be applied within 2 hours post surgery
Postoperative phase
- Pain assessment
Pain scores will be
recorded using the VAS score at fixed time intervals :
6,12,24,48, and 72 hours
postoperatively
- Adverse effects monitoring
Patient will be
monitored for opioid – related side
effects (nausea,vomiting,dizziness, respiratory depression)
- Patient
satisfaction
|