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CTRI Number  CTRI/2025/08/093882 [Registered on: 29/08/2025] Trial Registered Prospectively
Last Modified On: 29/08/2025
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   This study compares the effectiveness of External Oblique Intercostal Nerve Block (EOIB) and Modified Thoracoabdominal Nerve Block (M-TAPA) in managing postoperative pain and reducing opioid consumption in patients undergoing laparoscopic gallbladder removal surgery 
Scientific Title of Study   Efficacy of External Oblique Intercostal Block (EOIB) Vs Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) for post-operative pain in Laparoscopic Cholecystectomy - A randomized controlled trial 
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 Mitali Saxena 
Designation  Postgraduate trainee -1 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Anaesthesiology, 3rd floor OT Complex, Kalinga Institute of Medical Sciences and Pradyumna Bal Memorial Hospital, KIIT University, Patia, Bhubaneshwar
Department of Anaesthesiology, 3rd floor OT Complex
Khordha
ORISSA
751024
India 
Phone  9990887736  
Fax    
Email  mitalisaxena92@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr T Rajmohan Rao 
Designation  Professor 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Anaesthesiology, 3rd floor OT Complex, Kalinga Institute of Medical Sciences and Pradyumna Bal Memorial Hospital, KIIT University, Patia, Bhubaneshwar
Department of Anaesthesiology, 3rd floor OT Complex
Khordha
ORISSA
751024
India 
Phone  9701185818  
Fax    
Email  trajmohan.rao@kims.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Chandra Sekhar Pradhan 
Designation  Assistant Professor 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Anaesthesiology, 3rd floor OT Complex, Kalinga Institute of Medical Sciences and Pradyumna Bal Memorial Hospital, KIIT University, Patia, Bhubaneshwar
Department of Anaesthesiology, 3rd floor OT Complex
Khordha
ORISSA
751024
India 
Phone  8763584087  
Fax    
Email  chandrasekhar.pradhan@kims.ac.in  
 
Source of Monetary or Material Support  
Kalinga Institute of Medical Sciences(Infrastructure support),KIIT University, Patia, Khordha, Bhubaneswar, India Pin code - 751024 
 
Primary Sponsor  
Name  Kalinga Institute of Medical Sciences 
Address  KIMS hospital, KIIT university, KIIT Rd, Bhubaneswar- 751024, Odisha  
Type of Sponsor  Private 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 Mitali Saxena  Kalinga Institute of Medical Sciences   Department of Anesthesiology, 3rd floor OT Complex, KIMS and Pradyumna Bal Memorial Hospital, KIIT Deemed to be University, Patia, Bhubaneswar Khordha ORISSA
Khordha
ORISSA 		 9990887736

mitalisaxena92@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - Kalinga Institute of Medical Sciences (IEC KIMS))  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 
Comparator Agent  Efficacy of External Oblique Intercostal Block (EOIB) Vs Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M- TAPA) for post-operative pain in Laparoscopic Cholecystectomy  2.Group M (M-TAPA): Ultrasound-guided bilateral M-TAPA block with 40 ml of 0.25% ropivacaine + 50mcg dexmedetomidine on both sides post induction in laparoscopic gallbladder removal surgery lasting upto 2 hours.  
Intervention  Efficacy of External Oblique Intercostal Block (EOIB) Vs Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M- TAPA) for post-operative pain in Laparoscopic Cholecystectomy  1.Group E (EOIB): Ultrasound-guided bilateral EOIB block with 40 ml of 0.25% ropivacaine + 50mcg dexmedetomidine on both sides post induction in laparoscopic gallbladder surgery lasting upto 2 hours.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.American Society of Anesthesiologists (ASA) physical status I-II
2.Age 18-60 years
3.Patients posted for Laparoscopic cholecystectomy
4.Both male and female
 
 
ExclusionCriteria 
Details  1.Local site infection
2.Drug allergy
3.Contraindication to peripheral nerve blocks
4.Pre operative hypotension (MAP less than 70) and bradycardia (HR less than 50)
 
 
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 
To assess postoperative pain using visual analogue scale (VAS) score between the two groups at 12th hour  12th hour post surgery  
 
Secondary Outcome  
Outcome  TimePoints 
1. Total opioid consumption in postoperative period
2. Intraoperative- Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP) and, SpO2 baseline before induction.
3. Intraoperative- Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP) and, SpO2 and EtCO2 during surgery.
4. Time to the requirement of 1st dose of rescue analgesic in minutes.
5. Incidence of adverse effects like post op nausea and vomiting and sedation.
 		 1. Total opioid consumption in postoperative period
2. Intraoperative- Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP) and, SpO2 baseline before induction.
3. Intraoperative- Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP) and, SpO2 and EtCO2 every 10 mins interval till the end of surgery.
4. Time to the requirement of 1st dose of rescue analgesic in minutes.
5. Incidence of adverse effects like post op nausea and vomiting and sedation.
 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   10/09/2025 
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="2"
Months="0"
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  

Laparoscopic cholecystectomy is a common surgery to remove the gallbladder. Although less invasive, it can still cause significant pain after surgery, especially around the incision sites. Two newer pain relief methods, External Oblique Intercostal Block (EOIB) and Modified Thoracoabdominal Nerve Block (M-TAPA), use local anesthetic to numb nerves in the abdominal area. Both have been shown to reduce pain and lower the need for opioid medications. However, they haven’t been directly compared. This study aims to find out which method works better for pain control and recovery. The results could help improve patient comfort and reduce opioid use after surgery.

 
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