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CTRI Number  CTRI/2025/02/080750 [Registered on: 18/02/2025] Trial Registered Prospectively
Last Modified On: 10/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Study comparing bilateral external oblique intercostal plane block and subcostal transversus abdominis plane block to prevent post operative pain in laparoscopic cholecystectomy patients 
Scientific Title of Study   Comparison of the effectiveness of ultrasound guided bilateral external oblique intercostal plane block and subcostal transversus abdominis plane block for post operative analgesia management after laparoscopic cholecystectomy- Randomised double blinded study. 
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 Akshaya G 
Designation  Postgraduate resident - MD Anesthesiology 
Affiliation  Chettinad hospital and research institute 
Address  Dr Akshaya G, Postgraduate resident, Department of anesthesiology, Chettinad hospital and research institute,chettinad health city, rajiv gandhi salai(OMR), kelambakkam,Tamilnadu 603103

Kancheepuram
TAMIL NADU
603103
India 
Phone  8870455755  
Fax    
Email  akshayajothi14@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Merlin Shalini Ruth  
Designation  Professor 
Affiliation  Chettinad hospital and research institute 
Address  Professor, Department of Anesthesiology, Chettinad hospital and research institute,chettinad health city, rajiv gandhi salai(OMR), kelambakkam,Tamilnadu 603103

Chennai
TAMIL NADU
603103
India 
Phone  9790983957  
Fax    
Email  merlin5shalini@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Akshaya G 
Designation  Postgraduate resident - MD Anesthesiology 
Affiliation  Chettinad hospital and research institute 
Address  Dr Akshaya G, Postgraduate resident, Department of anesthesiology, Chettinad hospital and research institute,chettinad health city, rajiv gandhi salai(OMR), kelambakkam,Tamilnadu 603103

Chennai
TAMIL NADU
603103
India 
Phone  8870455755  
Fax    
Email  akshayajothi14@gmail.com  
 
Source of Monetary or Material Support  
chettinad hospital and research institute, chettinad health city, rajiv gandhi salai, kelambakkam, chennai, tamilnadu, india-603103 
 
Primary Sponsor  
Name  Chettinad hospital and research institute 
Address  Chettinad hospital and research institute, Chettinad Health City, rajiv gandhi salai, Kelambakkam, Tamilnadu 603103 
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 Akshaya G  Chettinad hospital and research institute  D- block, 1st floor, Department of Anesthesiology, chettinad health city, rajiv gandhi salai, kelambakkam, chennai, tamilnadu, India - 603103
Chennai
TAMIL NADU 
8870455755

akshayajothi14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committe For Student Research  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  External oblique intercostal plane block following endotracheal intubation  External oblique intercostal plane block using 20 ml of 0.25% Bupivacaine followed by endotracheal intubation for postoperative pain management in patients undergoing laparoscopic cholecystectomy and will be assessed postoperatively for the next 24 hours.  
Intervention  ultrasound guided subcostal transverse abdominis plane block in patients undergoing laparoscopic cholecystectomy  Subcostal transverse abdominis plane block using 20 ml of 0.25% Bupivacaine followed by endotracheal intubation for postoperative pain management in patients undergoing laparoscopic cholecystectomy and will be assessed postoperatively for the next 24 hours.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.American Society of Anesthesiologist (ASA) grade I-III.2.Age 18-65 years.
 
 
ExclusionCriteria 
Details  1.when laparoscopy converted to open. 2. Age >18 or above 65. 3.Patient refusal. 4.Local infection at the site of infection. 5. Abnormal coagulation profile. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the requirement of tramadol   First 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To compare hemodynamic stability, quality of recovery index of the group, intensity of pain using VAS score.  First 24 hours 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 4 
Date of First Enrollment (India)   27/02/2025 
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="1"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   To compare the effectiveness of ultrasound guided Bilateral external oblique intercostal plane block,  subcostal transversus abdominis plane block - a randomized double blinded study.

PRIMARY OBJECTIVES

To compare the requirement of tramadol in first 24 hours.

SECONDARY OBJECTIVES

To compare the hemodynamic stability between the study groups
To compare the quality of recovery index of the groups.
To compare the intensity of using VAS score.
Inclusion criteria :
1)Age - 18-65 years.
2)American society of anesthesiologist (ASA) grade – I,II,III
Exclusion criteria :
1)Patient refusal.
2)Age - < 18, > 65 years of age.
3)Local infection at the site of block.
4)When laparoscopic surgery converted to open.
5)Abnormal coagulation profile.
METHODOLOGY
1)Study design: Prospective, randomised, double blinded, case study.
2)Study population: After obtaining approval by the institutional ethics committee and CTRI registration, written and informed patient consent, 20 patients on each group under ASA physical status I,II,III patients scheduled for laparoscopic cholecystectomy at Chettinad Hospital and Research Institute, Kelambakkam, Chennai.
3)Sample size: Sample size is calculated using the formula for difference in means with alpha error of 5% and power 80% using data from the study of Saudi medical journal- Muhammet korkusuz, Betul basaran, Tayfun et, Aysegul bilge, Rafet yarimoglu, Hasan Yildirim. Biateral external oblique intercostal plane block in patients undergoing laparoscopic cholecystectomy. 2023;10: 1037-1045- 20 per group.
PREOPERATIVE ASSESSMENT:
-Detailed history and physical examination, baseline data like HR,BP and basic investigations will be collected.
-An IV access with 18G IV cannula will be secured for all patients.
-Premedication such as Tab Pantoprazole 40mg and Tab Anxit 0.5mg given a night before surgery and 6 am on the day of surgery.
INTRA-OPERATIVE ASSESSMENT:
-Proper standard monitoring of SpO2, NIBP, ECG will be established and baseline variable values will be noted before the procedure.
-Patient will undergo GA induction with IV propofol 2mg/kg, IV fentanyl 1-2mcg/kg, IV atracurium 0.5-0.7mg/kg.
-Tracheal intubation was then performed approximately 3 mins after anesthesia induction.
-Mechanical ventilation was conducted using Volume controlled mode with a tidal volume of 6-8 ml/kg, resulting in an end tidal CO2 pressure range of 35-40 mmHg.

EOIPB group:

-EOIPB was administered following the intubation. 
-The high frequency linear US probe will be covered with a sterile sheath, and an 80 mm block needle will be used.
-A linear USG transducer was positioned in the sagittal plane at the 6TH rib level between the anterior axillary and mid clavicular lines.
-The ribs , lungs, pleura, intercostal muscle, external oblique muscle and subcutaneous tissue was visualized in the image.
-EOIB is performed under US guidance is a block by injection of LA between the external and internal oblique muscles.
-The in- plane technique with a 22G, 80mm block needle, after negative pressure aspiration, 5ml saline will be injected and the block location will be confirmed.
-Once the block location is confirmed, 20ml of 0.25% bupivacaine will be injected bilaterally.
Subcostal TAPB group:
-TAPB was administered following the intubation.
-The US probe will be placed in the sagittal direction on the 10th costal margin in the midline and a deep angle was given to costochondral angle, and the external oblique abdominal muscle, internal oblique abdominal muscle, and the transverse abdominis muscle will be visualized.
-Then, using the in-plane technique, the needle will be advanced with the help of ultrasound until the needle tip reaches the space between the internal oblique and transverse abdominis muscles.
-After negative pressure aspiration, 5ml saline will be injected and the block location will be confirmed.
-Once the block location is confirmed, 20ml of 0.25% bupivacaine will be injected bilaterally.

 
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