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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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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