| CTRI Number |
CTRI/2023/12/060812 [Registered on: 27/12/2023] Trial Registered Prospectively |
| Last Modified On: |
22/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of postoperative pain and haemodynamic effects of Intraperitoneal instillation of Buprenorphine with Bupivacaine versus Bilateral transversus abdominis plane block using Buprenorphine with Bupivacaine for Laparoscopic Cholecystectomy: A Comparative study |
|
Scientific Title of Study
|
Evaluation of postoperative analgesic effects of Intraperitoneal instillation of Buprenorphine with Bupivacaine versus Bilateral transversus abdominis plane block using Buprenorphine with Bupivacaine for Laparoscopic Cholecystectomy: A Comparative 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 |
Dr Geetanjali M |
| Designation |
Associate professor |
| Affiliation |
BGS GLOBAL INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anaesthesiology, BGS Global Institute Of Medical Sciences, Karnataka
Bangalore
Bangalore
KARNATAKA
560060
India |
| Phone |
9739945846 |
| Fax |
|
| Email |
geetp11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetanjali M |
| Designation |
Associate professor |
| Affiliation |
BGS Global Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology, BGS Global Institute Of Medical Sciences,
Bangalore
Bangalore
KARNATAKA
560060
India |
| Phone |
9739945846 |
| Fax |
|
| Email |
geetp11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr H Sumana |
| Designation |
Junior Resident |
| Affiliation |
BGS Global Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology, BGS Global Institute Of Medical Sciences,
BANGALORE
Bangalore
KARNATAKA
560060
India |
| Phone |
8310888363 |
| Fax |
|
| Email |
sumanareddyhardageri@gmail.com |
|
|
Source of Monetary or Material Support
|
| BGS Global Institute Of Medical Sciences, Uttarahalli main road, Kengeri, Bangalore. Karnataka. 560060 |
|
|
Primary Sponsor
|
| Name |
BGS Global Institute Of Medical Sciences |
| Address |
BGS Global Institute Of Medical Sciences, Uttarahalli main road, Krngeri, Bangalore. Karnataka. 560060 |
| 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 H Sumana |
BGS Global Institute Of Medical Sciences |
BGS Global Institute of Medical Sciences, Kengeri, Bangalore. 560060
Bangalore
KARNATAKA |
8310888363
sumanareddyhardageri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BGS GLOBAL INSTITUTE OF MEDICAL SCIENCES Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
bilateral transversus abdominis plane block |
Bilateral subcostal transversus abdominis plane
block with 24 ml of 0.25% bupivacaine with
300mcg buprinorphine.
Duration of observation - 24 hours |
| Intervention |
intraperitoneal instillation |
Intraperitoneal instillation will 24ml of 0.25%
bupivacaine with 300mcg buprenorphine in the
gall bladder fossa , upper surface of liver and hepatorenal ligament.
duration- 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Physical status 1 and 2
Age group 18 to 60 years
Elective laparoscopic cholecystectomy posted
patients |
|
| ExclusionCriteria |
| Details |
ASA Physical status 3 and 4
Patients with history of anaphylaxis to local
anaesthetics and/or opioids or drugs to be used
Patients with history of drug abuse and
psychiatric disease
Morbidly obese patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative pain |
0min, 30min, 1hour, 2hour, 4hour, 8hour, 12hour, 16hour, 20hour and 24hour post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total rescue analgesic consumption in first 24 hrs
Hemodynamic parameters and complications in
next 24 hours |
24 hours after surgery |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
26/02/2024 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sumanareddyhardageri@gmail.com].
- For how long will this data be available start date provided 01-06-2025 and end date provided 31-12-2032?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
There are various pre-operative, intra- operative and post -operative pain
management strategies to inhibit or reduce post- operative pain like opoids, NSAID’s,
local anaesthetics infiltration, intraperitoneal instillation, thoracic epidural, trnversus
abdominis plane block. However, every single modality has certain limitations and
each technique was evaluated in different surgical procedures in several studies and
evaluation of both techniques in laparoscopic cholecystectomy is not extensively
studied. so we thought it is worthwhile to compare these two techniques. |