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CTRI Number  CTRI/2025/12/098957 [Registered on: 11/12/2025] Trial Registered Prospectively
Last Modified On: 09/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study comparing two methods of administering analgesia, TAP block and port site injection, for reducing pain after laparoscopic gall bladder removal surgery. 
Scientific Title of Study   A comparative study of the efficacy of sub costal transverses abdominis plane block Vs port site infiltration of local anesthetics in laparoscopic cholecystectomy A randomised double blind study 
Trial Acronym  TAP PORT TRIAL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Karanbabu Balu 
Designation  Postgraduate Resident, Department of Anesthesiology 
Affiliation  PSG Institute of Medical Sciences and Research 
Address  Off Avinashi Road, Peelamedu, Coimbatore

Coimbatore
TAMIL NADU
641004
India 
Phone  8220893460  
Fax    
Email  karanbabu602@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ganesan C 
Designation  Professor, Department of Anesthesiology 
Affiliation  PSG Institute of Medical Sciences and Research 
Address  Off Avinashi Road, Peelamedu, Coimbatore

Coimbatore
TAMIL NADU
641004
India 
Phone  9894769902  
Fax    
Email  sundaram_spm@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Karanbabu Balu 
Designation  Postgraduate Resident, Department of Anesthesiology 
Affiliation  PSG Institute of Medical Sciences and Research 
Address  Off Avinashi Road, Peelamedu, Coimbatore

Coimbatore
TAMIL NADU
641004
India 
Phone  8220893460  
Fax    
Email  karanbabu602@gmail.com  
 
Source of Monetary or Material Support  
PSG Hospitals, PSG Institute of Medical Sciences and Research 
 
Primary Sponsor  
Name  psg imsr 
Address  Post Box No. 1674, Off Avanashi Road, Peelamedu, Coimbatore-641 004, Tamil Nadu, India.  
Type of Sponsor  Research institution and hospital 
 
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 Karanbabu Balu  PSG Hospitals  Department of Anesthesiology, A block, Off Avinashi Road, Peelamedu, Coimbatore, Tamil Nadu, India Pincode: 641004
Coimbatore
TAMIL NADU 		 8220893460

karanbabu602@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee, PSG Institute of Medical Sciences and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Port Site Infiltration  Patients in this arm receive port site infiltration with the same local anesthetic solution. Bupivacaine 2 mg per kg with dexamethasone 0.1 mg per kg is divided equally and infiltrated at all port sites by the surgeon. 
Intervention  Subcostal TAP Block   Patients in this arm receive an ultrasound guided subcostal transversus abdominis plane block after induction of general anesthesia. The block is performed with bupivacaine 2 mg per kg with dexamethasone 0.1 mg per kg as a single shot injection. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Adult patients undergoing elective laparoscopic cholecystectomy.
2. ASA (American Society of Anesthesiologists) classification I or II.
3. No history of chronic opioid use.
4. Age 25 to 60 years
5. BMI not more than 35.
 
 
ExclusionCriteria 
Details  1. Patient refusal
2. Skin infections
3. Emergency surgeries
4. ASA 3 and 4
5. Pregnancy
6. Age less than 25 and more than 60 years
7. Patients allergic to local anesthetics 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
• To determine the analgesic efficacy of subcostal transversus abdominis plane block in patients undergoing laparoscopic cholecystectomy using visual analog score and numerical pain rating scale
• To determine the analgesic efficacy of port site infiltration of local anesthetics in patients undergoing laparoscopic cholecystectomy using visual analog score and numerical pain rating scale
• To compare the postoperative pain scores between the two groups using the Visual Analog Scale (VAS) and numerical pain rating scale (NMS).
 		 30 minutes / 1 hour / 2 hour / 4 hour
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the time to discharge from the recovery unit as an indicator of early postoperative recovery
2. To analyse the requirement of rescue analgesia (TRAMADOL) in the first four hours of the postoperative period in both groups & to compare the analgesic efficacy between them 		 30 minutes, 1 hour, 2 hours & 4 hours post extubation 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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   N/A 
Date of First Enrollment (India)   23/12/2025 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   This randomised double blind study compares the analgesic effect of the subcostal transversus abdominis plane block and port site infiltration of local anesthetics in patients undergoing laparoscopic cholecystectomy . Adult patients assigned to two groups . Group A receives an ultrasound guided subcostal TAP block . Group B recieves port site infiltration with local anesthetic . Pain scores are measures using visual analog scale at fixed time intervals . The study also evaluates time to first rescue analgesic and total postoperative analgesic requirement . The aim is to determine which technique provides better postoperative pain relief and improves early recovery . 
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