| 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
|
|
|
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
|
|
|
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. |