| CTRI Number |
CTRI/2024/07/070061 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Analgesic Efficacy Of Transdermal Buprenorphine For Postoperative Pain In Patients Undergoing Lumbar Discectomy |
|
Scientific Title of Study
|
Comparison Of Analgesic Efficacy Of Transdermal Buprenorphine For Postoperative Pain With Control Group In Patients Undergoing Lumbar Discectomy |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lekha Shree R |
| Designation |
Junior Resident |
| Affiliation |
Sapthagiri Institute Of Medical Sciences And Research Centre |
| Address |
Department Of Anaesthesia
Sapthagiri Institute Of Medical Sciences And Research Centre,
No. 15, Chikkasandra, Hesaraghatta Main Road, Bengaluru -560090 Karnataka India
Bangalore
KARNATAKA
560090
India |
| Phone |
8197358214 |
| Fax |
|
| Email |
lekhashree96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manjunath A C |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute Of Medical Sciences And Research Centre |
| Address |
Department Of Anaesthesia
Sapthagiri Institute Of Medical Sciences And Research Centre,
No. 15, Chikkasandra, Hesaraghatta Main Road, Bengaluru -560090 Karnataka India
Bangalore
KARNATAKA
560090
India |
| Phone |
8123540084 |
| Fax |
|
| Email |
manjumac5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manjunath A C |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute Of Medical Sciences And Research Centre |
| Address |
Department Of Anaesthesia
Sapthagiri Institute Of Medical Sciences And Research Centre,
No. 15, Chikkasandra, Hesaraghatta Main Road, Bengaluru -560090 Karnataka India
Bangalore
KARNATAKA
560090
India |
| Phone |
8123540084 |
| Fax |
|
| Email |
manjumac5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sapthagiri Institute Of Medical Sciences And Research Centre
No. 15, Chikkasandra, Hesaraghatta Main Road, Bengaluru -560090 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Sapthagiri Institute Of Medical Sciences And Research Centre |
| Address |
No. 15, Chikkasandra, Hesaraghatta Main Road, Bengaluru -560090 Karnataka India
|
| 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 Lekha Shree R |
Sapthagiri Institute Of Medical Sciences And Research Centre |
Department Of Anaesthesia
OT complex 4th floor
No. 15, Chikkasandra, Hesaraghatta Main Road, Bengaluru -560090
Karnataka, INDIA
Bangalore
KARNATAKA |
8197358214
lekhashree96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Buprenorphine |
Route- Transdermal
Dose- 10mcg/hr
Frequency- Applied night before surgery
|
| Comparator Agent |
Inj Paracetamol |
Inj Paracetamol 1g IV is used as a control given intraoperatively . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II
Age 18-60yrs
Posted for lumbar discectomy
|
|
| ExclusionCriteria |
| Details |
Patients not willing to participate in the study
Patients on any other form of opioid therapy for chronic pain
History of drug allergy or application
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare postoperative VAS score in patients receiving buprenorphine patch v/s control who wont receive buprenorphine patch |
VAS score , HR , BP , SPO2 will be assessed at 0, 2, 4, 8, 12, 24 and 48hrs in both the groups and recorded |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to first rescue analgesic.
Total rescue analgesic.
|
Time of first rescue analgesia, total analgesic consumption will be recorded in first 48 hours. |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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 3 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="1"
Months="0"
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
|
Transdermal patches for NSAIDS and opioids offer the advantage of sustained drug delivery, bioavailability, and avoidance of first-pass metabolism which reduces systemic effects. They have a one-time application, reduce workload on health-care workers, and prevent waxing-waning of analgesia due to diminishing blood levels.It has been widely applied in treating chronic low back pain displaying excellent results.This study is undertaken to see the effect of transdermal buprenorphine on postoperative pain after lumbar discectomy.
Patients posted for lumbar discectomy in Sapthagiri Institute of Medical Sciences who fulfil the inclusion criteria will be enrolled for the study. Patients will be randomised into 2 equal groups of 42 each [Group B and Group C] using computer generated table of random numbers. Group B: Receiving transdermal buprenorphine patch 10 mg the night before surgery Group C : Control group who will not receive buprenorphine patch Group B patients will receive transdermal Buprenorphine 10mcg/hr patch night before surgery. Analgesia IV Paracetamol 1g will be given after intubation in both groups. Intraoperative hemodynamic parameters like HR , BP , SPO2 will be noted at baseline, induction, 5 mins and 10 mins. VAS score , HR , BP , SPO2 will be assessed at 0, 2, 4, 8, 12, 24 and 48hrs in both the groups and recorded. Inj Tramadol 2 mg/kg (maximum 100mg) IV will be administered when VAS>3 as rescue analgesic.VAS score, time of first rescue analgesia, total analgesic consumption will be recorded in first 48 hours and compared between both groups.
|