| CTRI Number |
CTRI/2026/01/101200 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between the efficacy of two types of interventions External oblique rectus abdominis and Subcostal transverse abdominis plane block in pain relief in patients undergoing laparoscopic cholecystectomy |
|
Scientific Title of Study
|
Comparison of External Oblique and Rectus Abdominis Plane (EXORA) block with Subcostal Transverse Abdominis Plane (TAP) Block for post operative Analgesia in 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 |
Dr Shalmalee Sarkar |
| Designation |
PG Resident |
| Affiliation |
Command Hospital Eastern Command |
| Address |
Anaesthesia Department 2nd floor pre op room Command hospital Eastern Command 17 1E 10 Judges Court Road Alipore Kolkata
Anaesthesia Department 2nd floor pre op room Command hospital Eastern Command 17 1E 10 Judges Court Road Alipore Kolkata
Kolkata
WEST BENGAL
700027
India |
| Phone |
8527710746 |
| Fax |
|
| Email |
shalmalee.sarkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lt Col Akhil Goel |
| Designation |
PROFESSOR |
| Affiliation |
COMMAND HOSPITAL EASTERN COMMAND |
| Address |
Anaesthesia Department second floor pre op room Command Hospital Eastern Command Alipore Kolkata
Anaesthesia Department second floor pre op room Command Hospital Eastern Command Alipore Kolkata
Kolkata
WEST BENGAL
700027
India |
| Phone |
9923686533 |
| Fax |
|
| Email |
akhilgoel.in@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lt Col Kapil Ashok Kulkarni |
| Designation |
Assistant Professor |
| Affiliation |
command hospital eastern command |
| Address |
Anaesthesia Department Command Hospital Eastern Command
171E 10 Judges Court Road Alipore Kolkata 700027
Command Hospital Eastern Command
17 1E 10 Judges Court Road Alipore Kolkata 700027
Kolkata
WEST BENGAL
700027
India |
| Phone |
7340781858 |
| Fax |
|
| Email |
kapsguy07@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR SHALMALEE SARKAR |
| Address |
COMMAND HOSPITAL EASTERN COMMAND Anaesthesia Department 2nd floor 17 1E ALIPORE ROAD ALIPORE POLICE LINE ALIPORE KOLKATA WEST BENGAL 700027 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| SHALMALEE SARKAR |
Command hospital eastern command |
Anaesthesia Department 17 1E Alipore road Alipore police lines Alipore Kolkata West Bengal 700027
Kolkata
WEST BENGAL |
8527710746
shalmalee.sarkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| command hospital (EC) kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (3) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound Guided External Oblique And Rectus Abdominis Plane (EXORA) Block. 0.25% Bupivacaine injection
|
Comparison of External Oblique and Rectus Abdominis Plane (EXORA) Block with Subcostal Transverse Abdominis Plane (TAP) Block for postoperative analgesia in Laparoscopic Cholecystectomy |
| Comparator Agent |
Ultrasound Guided Subcostal Transversus Abdominis Plane block
0.25% Bupivacaine injection |
Comparison of External Oblique Rectus Abdominis Plane (EXORA) Block with Subcostal Transverse Abdominis Plane (TAP) block for postoperative analgesia in Laparoscopic Cholecystectomy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 to 65 years- ASA physical status classification I or II- Patients scheduled to undergo elective laparoscopic cholecystectomy - BMI less than 35 kg/m²- Patients who provide written informed consent to participate in the study |
|
| ExclusionCriteria |
| Details |
Patients unwilling to participate- Known allergy to local anaesthetic agents- Coagulopathy or those on anticoagulation therapy- Local infection at the injection site- History of chronic pain or current opioid usage- Conversion from laparoscopic to open cholecystectomy- Pregnant women
|
|
|
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 |
Postoperative Pain Intensity: Pain scores will be assessed using the Visual Analogue Scale (VAS) at multiple pre-defined time points within the first 24 hours after surgery in patients who receive either the EXORA or the subcostal TAP block
|
30 MINUTES
2,4,6,12 & 24 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Temporal Pain Assessment: To evaluate the duration of analgesic effect by measuring the time to first rescue analgesic request
2. Analgesic Consumption Analysis: To quantify and compare the total consumption of rescue analgesics in both groups during the first 24 hours postoperatively
3. Safety Profile Evaluation: To assess and compare the incidence of block-related complications and adverse events between the two techniques
|
FIRST 24 HOURS |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
30/01/2026 |
| 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="4"
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
|
Comparison of EXORA Block and Subcostal TAP Block for Postoperative Analgesia in Laparoscopic Cholecystectomy.
In recent years, regional anaesthesia, particularly abdominal wall blocks, has become a key component of multimodal analgesia due to their opioid-sparing effects and efficacy in managing postoperative pain. One such technique, the subcostal transversus abdominis plane (TAP) block, involves injecting local anaesthetic between the internal oblique and transversus abdominis muscles to target the anterior branches of thoracic spinal nerves (T6–T12). It has demonstrated effectiveness in providing analgesia for upper abdominal surgeries, including laparoscopic gallbladder removal, by covering the dermatomes linked to surgical and visceral pain in that area. More recently, a novel block known as the External Oblique and Rectus Abdominis Plane (EXORA) block has been introduced. This technique targets the interfascial plane between the external oblique and rectus abdominis muscles, aiming to block the anterior cutaneous branches of thoracoabdominal nerves (T6–T9) that innervate the gallbladder and upper abdominal wall. The local anaesthetic is administered between these two muscles to potentially offer more localized pain relief in the upper abdominal region. Although promising, there is currently limited clinical research directly comparing its effectiveness to that of the subcostal TAP block.
The present study seeks to compare EXORA and subcostal TAP blocks in the context of postoperative pain relief, need for additional analgesics, and overall patient satisfaction following laparoscopic cholecystectomy. This comparison aims to determine whether EXORA block can be considered a viable or even superior alternative to the more established subcostal TAP technique in routine surgical practice. |