| CTRI Number |
CTRI/2024/07/070462 [Registered on: 11/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Pain relief with BUPIVACAINE after cholecystectomy |
|
Scientific Title of Study
|
Postoperative pain relief with intraperitoneal bupivacaine after laparoscopic cholecystectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Satya |
| Designation |
General surgery post graduate resident |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Department of general surgery,
Sri Ramachandra institute of higher education and Research.
Chennai TAMIL NADU 600116 India |
| Phone |
8870894021 |
| Fax |
|
| Email |
Satyabala2015@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Raja Senthil |
| Designation |
Professor |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Department of general surgery,
Sri Ramachandra institute of higher education and research.
Chennai TAMIL NADU 600116 India |
| Phone |
9442569625 |
| Fax |
|
| Email |
rajasenthilv@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Satya |
| Designation |
post graduate resident |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Department of general surgery,
Sri Ramachandra institute of higher education and research.
Chennai TAMIL NADU 600116 India |
| Phone |
8870894021 |
| Fax |
|
| Email |
Satyabala2015@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra institute of higher education and research, Porur, Chennai, Tamil Nadu , India
PIN code- 600116
|
|
|
Primary Sponsor
|
| Name |
Dr Satya |
| Address |
Sri Ramachandra institute of higher education and research. |
| 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 Satya |
Sri Ramachandra institute of higher education and research. |
Department of General surgery, Sri Ramachandra institute of higher education and research, Porur, Chennai, 6001116
Chennai TAMIL NADU |
8870894021
Satyabala2015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional research ethics committee, Sri Ramachandra institute of higher education and research, Porur, Chennai , Tamil Nadu. 600116. |
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 |
Intraperitoneal instillation of BUPIVACAINE |
Patients undergoing laparoscopic cholecystectomy in test group will receive 20 ml of 0.25% BUPIVACAINE administered via cannula into the region of gallbladder bed after the gallbladder is dissected. Control group will not receive any medications.
Dose- 20ml of 0.25% BUPIVACAINE
Instilled over the GB bed once.
Duration- 5 minutes |
| Comparator Agent |
Placebo |
For the patients in the control group, no drug is administered during laparoscopic cholecystectomy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
1. Known allergy to local anaesthetics.
2. Known cardiac issues.
3. Procedures converted to open cholecystectomy.
4. Patients who do not consent.
5. Patients with acute cholecystitis.
6. Patients undergoing interval cholecystectomy. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Postoperative pain score by visual analogue pain scale
|
0,2,4,6 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Analgesic usage
Time taken to start mobilizing
Duration of hospital stay |
24 hours and at discharge |
|
|
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)
|
01/08/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 randomized control trial with a sample size of 30 in each group. After getting the approval from the institution ethics committee, patients who satisfy the inclusion criteria and exclusion criteria will be included in the study. All patients will be admitted and a detailed history, relevant clinical examination and relevant investigations will be done. After establishing the diagnosis, the patients will be subjected to Laparoscopic cholecystectomy. After obtaining consent, Patients will be randomly allotted into blocks and separated into control group and test group. Patients in test group will receive 20 ml of 0.25% BUPIVACAINE administered via cannula into the region of gallbladder bed after the gallbladder is dissected. The patients in control group will not receive any medications intraoperatively. Both the groups will be assessed with visual analogue pain scale with a score of 0-10 at 0 hr, 2 hr, 4 hr, 6 hr and at 12 hours post surgery. Patients will be prescribed INJ. TRAMADOL 50mg intravenous sos. Drug utilization will be reviewed at 24 hours. Time taken to start mobilizing and duration of stay are noted. Pain score, analgesic usage, postoperative nausea, time to mobilize and duration of stay are compared between the two groups and analyzed.
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