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CTRI Number  CTRI/2025/11/097342 [Registered on: 13/11/2025] Trial Registered Prospectively
Last Modified On: 12/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between two types of facial plane blocks (EXORA and TAP) in patients undergoing laproscopic cholecystectomy surgeries 
Scientific Title of Study   Efficacy of external and rectus abdominus plane (EXORA) block versus subcostal transversus abdominus plane(TAP) block in laaroscopic cholecystectomy surgeries 
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 Naseef Sakkir  
Designation  PG Resident 
Affiliation  Armed Forces Medical College Pune 
Address  Department of Anaesthesiology AFMC Pune, Wanowrie Pune

Pune
MAHARASHTRA
411040
India 
Phone  9020635837  
Fax    
Email  naseef.sm@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aditya Sapra 
Designation  HoD, Department of Anaesthesia 
Affiliation  AFMC 
Address  Department of Anaesthesiology AFMC pune

Pune
MAHARASHTRA
411040
India 
Phone  8197084270  
Fax    
Email  adityasapra@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aditya Sapra 
Designation  HoD, Department of Anaesthesia 
Affiliation  AFMC 
Address  Department of Anaesthesiology AFMC pune

Pune
MAHARASHTRA
411040
India 
Phone  8197084270  
Fax    
Email  adityasapra@gmail.com  
 
Source of Monetary or Material Support  
Command Hospital, Southern Command, Pune 
 
Primary Sponsor  
Name  Armed Forces Medical College Pune 
Address  Command hospital southern command, Pune 
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 
Dr Naseef  Operation Theatre complex, Command Hospital Pune  Dept of Anaesthesiology, AFMC
Pune
MAHARASHTRA 
9020635837

naseef.sm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AFMC PUNE  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  Fascial Plane block   15 mL of 0.25% bupivacaine (total 30 mL per side) will be injected into the fascial plane between the external oblique and rectus abdominis muscles, targeting the T6–T9 anterior cutaneous branches of the thoracoabdominal nerves 
Comparator Agent  TAP block  15 mL of 0.25% bupivacaine (total 30 mL per side) will be deposited into the fascial plane between the internal oblique and transversus abdominis muscles on each side, targeting the anterior branches of the thoracic intercostal nerves (T6–T12). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA I & II patients
18 years to 65 years
ASA physical status I or II
Patients undergoing elective laparoscopic cholecystectomy
BMI less than 35
Consent to participate in the study
 
 
ExclusionCriteria 
Details  Patients who deny consent will not be included in the study
Allergy to local anaesthetics
Coagulopathy or anticoagulant therapy
Infection at the site of block
Chronic pain disorders or opioid use
Conversion to open cholecystectomy
Pregnancy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate and compare time to first rescue analgesic request between the EXORA block and subcostal TAP block groups in patients undergoing laparoscopic cholecystectomy  18 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the postoperative pain scores using the Visual Analogue Scale (VAS) at specified time intervals within the first 24 hours between the study groups.
2. To monitor any block related complications or side effects between the study groups.
 
18 months 
 
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 1/ Phase 2 
Date of First Enrollment (India)   24/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  24/11/2025 
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 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  

The methodology for this prospective, randomized, double-blinded, comparative study will commence with patient enrollment at a tertiary care hospital in Western Maharashtra, where adult patients scheduled for elective laparoscopic cholecystectomy under general anesthesia will be screened for eligibility based on inclusion and exclusion criteria. Eligible patients, aged 18–65 years with ASA physical status I or II and BMI < 35 kg/m², will provide written informed consent following a detailed explanation of the study. Patients will be allocated to one of two groups—Group A (EXORA block) or Group B (subcostal TAP block)—using block randomization with allocation concealment ensured via sealed opaque envelopes.

Prior to surgery, bilateral blocks will be administered under ultrasound guidance by an experienced anaesthesiologist using a high-frequency linear probe (6–13 MHz). For the EXORA block group, 15 mL of 0.25% bupivacaine (total 30 mL per side) will be injected into the fascial plane between the external oblique and rectus abdominis muscles, targeting the T6–T9 anterior cutaneous branches of the thoracoabdominal nerves. For the subcostal TAP block group, the same volume and concentration of bupivacaine will be deposited between the internal oblique and transversus abdominis muscles, targeting the T6–T12 thoracic intercostal nerves.

A standardized general anesthesia protocol will be followed, using propofol (2–3 mg/kg), fentanyl (2 µg/kg), and rocuronium (0.6–1 mg/kg) for induction, and sevoflurane (1–2%) for maintenance, with surgery performed via a standard four-port laparoscopic cholecystectomy technique.

Postoperatively, patients will receive intravenous paracetamol (1 g every 6 hours) as the first-line analgesic, with intravenous tramadol (50 mg) as rescue analgesia for VAS scores exceeding 4. Pain intensity at rest and during movement (coughing or sitting up) will be assessed using the Visual Analogue Scale (VAS, 0–10) at 30 minutes, 2, 4, 6, 12, and 24 hours post-surgery by blinded outcome assessors. Secondary outcomes, including time to first rescue analgesic request, total tramadol consumption (converted to morphine equivalents), block-related complications (e.g., haematoma,

vomiting), patient satisfaction (via a 5-point Likert scale), and block performance time, will be recorded in a structured proforma. Sensory blockade will be evaluated post-block using a pinprick test to confirm dermatomal coverage.

 
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