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CTRI Number  CTRI/2023/01/048887 [Registered on: 11/01/2023] Trial Registered Prospectively
Last Modified On: 13/06/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of painkillers and its comparison with local injection in laparoscopic (key hole surgery ) for gall bladder stone surgery  
Scientific Title of Study   Efficacy of the laparoscopic subcostal transversus abdominis plane block vs conventional analgesia in laparoscopic cholecystectomy: a randomized controlled trial 
Trial Acronym  STAP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Agrawal Kavita Khemchand 
Designation  Assistant Professor 
Affiliation  Dr. B. R. Ambedkar Institute of Medical Sciences, MOHALI 
Address  Department of General Surgery, Room 103, First floor ,Block 1 District hospital, Mohali

Rupnagar
PUNJAB
160055
India 
Phone  7087438617  
Fax    
Email  drkavitaagrawal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Agrawal Kavita Khemchand 
Designation  Assistant Professor 
Affiliation  Dr. B. R. Ambedkar Institute of Medical Sciences, MOHALI 
Address  Department of General Surgery, Room 103, First floor ,Block 1 District hospital, Mohali

Rupnagar
PUNJAB
160055
India 
Phone  7087438617  
Fax    
Email  drkavitaagrawal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Agrawal Kavita Khemchand 
Designation  Assistant Professor 
Affiliation  Dr. B. R. Ambedkar Institute of Medical Sciences, MOHALI 
Address  Department of General Surgery, Room 103, First floor ,Block 1 District hospital, Mohali

Rupnagar
PUNJAB
160055
India 
Phone  7087438617  
Fax    
Email  drkavitaagrawal@gmail.com  
 
Source of Monetary or Material Support  
Dr. B. R. Ambedkar State Institue of Medical Sciences, mohali 
 
Primary Sponsor  
Name  Dr. B. R. Ambedkar State Institue of Medical Sciences, mohali 
Address  phase 6, Mohali, 160055 
Type of Sponsor  Government medical college 
 
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 
Agrawal Kavita Khemchand  Dr. B. R. Ambedkar state Institute of medical sciences   first floor, district hospital, Mohali
Rupnagar
PUNJAB 		 7087438617

drkavitaagrawal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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  STAP Block ropivacaine group  20ml of 0.25% ropivacaine instilled laparoscopic guided transverses abdominis plane before surgical closure 
Comparator Agent  conventional analgesia (intravenous diclofenac)  conventional analgesia consisting of intravenous injection of diclofenac 75mg given 8th hourly in postoperative period 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Age >18-80 years
2. Patients scheduled to undergo laparoscopic cholecystectomy
 
 
ExclusionCriteria 
Details  1. Patient refusal to give consent to participate in the study
2. Patients with history of allergy to local anesthetics
3. Patients who get converted to open cholecystectomy
4. Patients with acute cholecystitis
5. Significant liver or renal disease
6. Abdominal drain use
7. Opioid addict patients
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Evaluation of visual analog scale score during first 24 hours post operatively.  Evaluation of visual analog scale score at extubation, 1,2,3,6,12, and 24 hours post operatively 
 
Secondary Outcome  
Outcome  TimePoints 
requirement of rescue analgesia  0, 4, 8, 12, 16, 20, 24 hours postoperatively 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   15/01/2023 
Date of Study Completion (India) 12/06/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drkavitaagrawal@gmail.com].

  6. For how long will this data be available start date provided 01-04-2023 and end date provided 01-10-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Many patients experience moderate to severe pain after laparoscopic cholecystectomy. Some studies have shown beneficial effects of subcostal transversus abdominis plane block on reducing this pain and opioid requirement following the surgery. Thus, it may also improve the efficiency by reducing time to discharge. Laparoscopic-guided subcostal TAP block is an alternate technique where ultrasound or its technical expertise are not available. Our goal is to investigate efficacy of laparoscopic subcostal TAP block vs conventional analgesia in patients undergoing laparoscopic cholecystectomy. 
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