| CTRI Number |
CTRI/2025/08/093020 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating the effect of buprenorphine patch applied prior surgery for postoperative pain relief applied before surgery in patients with femur fracuture |
|
Scientific Title of Study
|
Buprenorphine patch as a preemptive analgesia in fracture femur
patients - A prospective randomized controlled 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 |
Om vasavi palam |
| Designation |
MD Student |
| Affiliation |
Nizams Institute of medical sciences, Hyderabad |
| Address |
Nizams Institute of medical sciences, panjagutta , Hyderabad
Hyderabad
TELANGANA
500082
India |
| Phone |
8332922102 |
| Fax |
|
| Email |
pom.vasu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sapna Nikhar |
| Designation |
Associate professor |
| Affiliation |
Nizams Institute of medical sciences, Hyderabad |
| Address |
Nizams Institute of medical sciences, panjagutta, Hyderabad
Hyderabad
TELANGANA
500082
India |
| Phone |
9030460262 |
| Fax |
|
| Email |
sapnanikhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sapna Nikhar |
| Designation |
Associate professor |
| Affiliation |
Nizams Institute of medical sciences, Hyderabad |
| Address |
Nizams Institute of medical sciences, panjagutta, Hyderabad
TELANGANA
500082
India |
| Phone |
9030460262 |
| Fax |
|
| Email |
sapnanikhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nizams Institute of medical sciences, Hyderabad |
|
|
Primary Sponsor
|
| Name |
Om vasavi palam |
| Address |
Nizams Institute of medical sciences, Hyderabad,500082 |
| 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 Om vasavi palam |
NIMS |
Department of Anesthesiology, NIMS,Hyderabad,500082,Telangana
Hyderabad
TELANGANA |
8332922102
pom.vasu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nizams institute of medical sciences ethics committee |
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 |
group 1 |
Group-1 will receive buprenorphine patch of 10 mg 24 hours prior to surgery. Baseline VAS Score will be recorded, at the time of mobilisation,at positioning for subarachnoid block and postoperativelyat 4,8,12,24 hourly and compared between 2 groups. |
| Comparator Agent |
group 2 |
Group-2 will receive placebo patch applied 24 hrs prior surgery. Baseline VAS Score will be recorded, at the time of mobilisation,at positioning for subarachnoid block and postoperativelyat 4,8,12,24 hourly and compared between 2 groups. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients requiring fracture femur surgeries under subarachnoid blocks |
|
| ExclusionCriteria |
| Details |
1- Patients who are not willing to participate
2- Patients with multiple fractures that would add to the discomfort and need of epidural
3- Obese patients
4- Severe liver or cardiorespiratory disease
5- Altered mental status
6- Patients on antidepressants
7- Patients with allergic history to opioids
8- Patients with chronic pain because of some other conditions or having arthritic pain.
9- Conditions requiring general anesthesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess effectiveness of buprenorphine patch applied preoperatively 24 hours prior as perioperative analgesia |
4 hours, 8 hours, 12 hours and 24 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1- To assess analgesic requirements
2- To assess patient satisfaction
3- To assess development of any complications like respiratory depression, nausea, vomiting, shivering, pruritus and hemodynamic instability. |
With the above study we will be assessing the analgesic requirements or development of any complications during preoperative intraoperative or postoperative period. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 2/ Phase 3 |
|
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="1"
Months="0"
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
|
A prospective observational study which will be conducted on 80 patients divided into 2 groups with 40 patients in each group of either gender belonging to ASA1 or ASA2 status, aged 18-60 years old, requiring fracture femur surgery under subarachnoid block. Group I- will receive buprenorphine patch of 10mg 24 hours prior surgeryGroup II- will receive placebo patch.
The transdermal patch will be applied 24 h preoperatively, as preemptive analgesia to get maximum benefit as plasma concentration increases only slowly within 12–24 h.
Baseline VAS along with vitals was recorded in the form of heart rate, blood pressure, saturation and respiratory rate. Followed by VAS which will be recorded on the day of surgery at 8am, at the time of mobilization, at positioning for subarachnoid block and postoperatively at 4, 8, 12 and 24 hourly. Visual analogue scale (VAS) will be used to evaluate the degree of pain in patients: 0 to 2 scores indicated excellent; 3 to5 scores indicated good; 6 to8 scores indicated fair; and 9 to 10 scores indicated poor. The need of rescue analgesia will be recorded. The rescue analgesia will be given if VAS >4. The first rescue will be 1g paracetamol intravenously. If still VAS is more than 4, then ketorolac 30 mg, fllowed by 75 mg diclofencac intravenously will be used. The requirement of rescue analgesics will be in terms of ketorolac equivalents- 30 mg = 1g PCM=75 mg diclofenac. Total analgesic required in first 24 hours will be noted and any further intervention to reduce pain will also be noted |