| CTRI Number |
CTRI/2024/03/064238 [Registered on: 15/03/2024] Trial Registered Prospectively |
| Last Modified On: |
07/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of two different opioids in two different routes for postoperative analgesia in patients undergoing major abdominal surgeries |
|
Scientific Title of Study
|
A comparative study between transdermal buprenorphine patch versus intravenous fentanyl for postoperative analgesia in patients undergoing major abdominal surgeries under general anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Sahana BV |
| Designation |
PG Student, MD Anaesthesia |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of Anaesthesiology, Bangalore medical college and research institute
No 19, kaveri nilaya, SNT street, sreenivasanagar, bangalore, 560085
Bangalore
KARNATAKA
560002
India |
| Phone |
9686177897 |
| Fax |
|
| Email |
sahanavenkatramu1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asha N |
| Designation |
Assistant professor |
| Affiliation |
bangalore medical college and research institute |
| Address |
Department of anaesthesiology,bangalore medical college and research institute,KR Road, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9900622335 |
| Fax |
|
| Email |
ashamshu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asha N |
| Designation |
Assistant professor |
| Affiliation |
bangalore medical college and research institute |
| Address |
Department of anaesthesiology,bangalore medical college and research institute,KR Road, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9900622335 |
| Fax |
|
| Email |
ashamshu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore medical college and research institute, KR road, Bangalore, 560002 |
|
|
Primary Sponsor
|
| Name |
Bangalore medical college and research institute |
| Address |
Bangalore medical college, research institute, kr road,560002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Asha N |
Bangalore medical college, research institute, kr road,560002 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sahana BV |
Bangalore medical college and research institute |
Department of Anesthesiology, Bangalore medical college and research institute, KR road, 560002
Bangalore
KARNATAKA |
9686177897
sahanavenkatramu1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore medical college and research institute ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
post operative patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous fentanyl |
25mcg every 6th hourly for 3 days postoperatively |
| Intervention |
transdermal buprenorphine patch 5mcg/H |
applied over hairless areas for 3 days post operatively |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with weight 40-80kgs.
Patients scheduled for open elective intraperitoneal abdominal surgeries under general anaesthesia
Patients giving informed written consent.
Patients belonging to ASA I, II.
|
|
| ExclusionCriteria |
| Details |
1.Patients who refused to give informed written consent.
2.Patients with ASA physical status III or more.
3.Patients with known cardiac and pulmonary complications.
4.Patients with known allergy to opioids.
5.Patients with mental illness.
6.Pregnants and breastfeeding females.
7. Surgeries of duration > 3 hours.
8. Surgeries including surgical incision extended 5 cm above the umbilicus.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
visual analogue scale
|
Post operative day 1 to day 3
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
ramsay sedation scale
hemodynamic parameters
adverse effects |
post operative day 1 to 3 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
29/03/2024 |
| 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 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
|
Post operative pain is very common in major abdominal surgeries, and one of the major concerns for the patient undergoing major surgery. Pain in the first few days after surgery can lead to delayed ambulation, increase in cardiopulmonary and thrombotic morbidity as well the development of chronic pain. Appropriate pain relief leads to shortened hospital stays, reduced hospital costs, increased patient satisfaction. Opioid is generally regarded as an important part of multimodal, perioperative analgesia, especially for moderate to severe pain. •Buprenorphine is a semisynthetic opioid derivative of thebaine, being a potent and safe analgesic (75-100 times greater than that of morphine) at 5-10% receptors occupancy, causing less respiratory depression. Time to attain minimum therapeutic concentration after transdermal patch is 21 hours. Fentanyl is a potent synthetic opioid similar to morphine, but produces analgesia to great extent. IV Fentanyl has an appropriate effectiveness in acute pain relief and suitable doses have comparable effects to morphine, with shorter onset of action being 30-60 mins, onset of action being 60 seconds. Traditional and most common approach of post operative analgesia includes usage of opioid drug like morphine or fentanyl taken intravenously. Transdermal opioids are newer modality in use for the control of postoperative pain, because of its non invasiveness, longer duration of action, sustained blood levels and with minimal side effects There fore, the need of this study is to compare between traditional and standard approach- Intravenous fentanyl versus newer modality transdermal buprenorphine in the management of post operative pain, as there are very few studies quoted about them. our study is randomized study conducted in bangalore medical college and research institute conducted in 30 patients, 15 patients receiving transdermal buprenorphine as post operative analgesia and other 15 receiving intravenous fentanyl as postoperative analgesia. postoperatively pain will be asssessed by visual analogue scale, ramsay sedation score, hemodynamic parameters. adverse effects caused by both the groups noted. |