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CTRI Number  CTRI/2024/11/076946 [Registered on: 18/11/2024] Trial Registered Prospectively
Last Modified On: 08/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Other (Specify) [ REGIONAL ANESTHESIA BLOCK]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Postoperative pain relief with regional blocks after laparoscopic surgery. 
Scientific Title of Study   USG-Guided External Oblique Intercostal Plane block vs Modified Thoracoabdominal nerves plane Block for postoperative analgesia in patients undergoing 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  POOJA KESHWANI 
Designation  RESIDENT 
Affiliation  L H HIRANANDANI HOSPITAL 
Address  2nd Floor Department of Anesthesia
L H Hiranandani Hospital Powai.
Mumbai (Suburban)
MAHARASHTRA
400076
India 
Phone  9978503391  
Fax    
Email  poojakeshwani.97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  UJJWALRAJ DUDHEDIA 
Designation  HEAD OF DEPARTMENT  
Affiliation  L H HIRANANDANI HOSPITAL 
Address  2nd Floor Department of Anesthesia
L H Hiranandani Hospital Powai
Mumbai (Suburban)
MAHARASHTRA
400076
India 
Phone  9022801230  
Fax    
Email  ujjwalraj9775@gmail.com  
 
Details of Contact Person
Public Query  
Name  UJJWALRAJ DUDHEDIA 
Designation  HEAD OF DEPARTMENT  
Affiliation  L H HIRANANDANI HOSPITAL 
Address  2nd Floor Department of Anesthesia
L H Hiranandani Hospital Powai
Mumbai (Suburban)
MAHARASHTRA
400076
India 
Phone  9022801230  
Fax    
Email  ujjwalraj9775@gmail.com  
 
Source of Monetary or Material Support  
L. H. Hiranandani Hospital Hill side Avenue, Hiranandani gardens Powai 400076 Mumbai, Maharashtra 
 
Primary Sponsor  
Name  L H Hiranandani Hospital 
Address  Hill side Avenue, Hiranandani gardens Powai 400076 Mumbai, Maharashtra 
Type of Sponsor  Research institution and hospital 
 
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 
POOJA KESHWANI  L H HIRANANDANI HOSPITAL  2nd Floor Department of Anesthesia L H Hiranandani Hospital Hill side Avenue, Hiranandani gardens Powai 400076
Mumbai (Suburban)
MAHARASHTRA 		 9978503391

poojakeshwani.97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
L H Hiranandani hospital ethics commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K810||Acute cholecystitis, (2) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, (3) ICD-10 Condition: K807||Calculus of gallbladder and bile duct without cholecystitis, (4) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (5) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (6) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (7) ICD-10 Condition: K819||Cholecystitis, unspecified, (8) ICD-10 Condition: O||Medical and Surgical, (9) ICD-10 Condition: K808||Other cholelithiasis, (10) ICD-10 Condition: K822||Perforation of gallbladder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  0.25% LEVO-BUPIVACAINE - USG GUIDED EXTERNAL OBLIQUE BLOCK  Group A will receive a USG-guided external Oblique Intercostal Plane block with 30 ml of 0.25% LEVO-BUPIVACAINE and a Phrenic nerve Block with 4 ml of 0.125% LEVO-BUPIVACAINE on the right side.  
Intervention  0.25% LEVO-BUPIVACAINE - USG GUIDED MODIFIED THORACOABDOMINAL PLANE BLOCK  Group B will receive a USG Guided Modified Thoracoabdominal nerve plane Block with 30 ml of 0.25% LEVO-BUPIVACAINE and a Phrenic nerve block with 4ml of 0.125% LEVO-BUPIVACAINE on the Right side  
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  ASA Grade I and II patients
Weight : 45 – 108 Kgs
Height : 152 – 188 cms
Surgical ports exclusively on right side of the abdominal wall.
 
 
ExclusionCriteria 
Details  ASA Grade more than II
Patients with known allergies to any of the medicines used in the surgery
Patients not willing to participate in study.
Pregnant female.
Cardiopulmonary disorders.
Patients with diaphragmatic or Pulmonary disease such as – COPD, Bronchiectasis, ILD, Asthma.
Skin condition precluding the block. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of External oblique intercostal plane (EOI) block vs Modified Thoracoabdominal nerves Block through Perichondrial approach (M-TAPA)  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate requirement of intraoperative opioids.
To evaluate postoperative surgical site pain and shoulder tip pain.
To evaluate duration of first postoperative rescue analgesia consumption. 		 1 year 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   18/12/2024 
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="0"
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   Pain after laparoscopic abdominal surgery is clinically important. It has been demonstrated that regional Anesthesia reduces the incidence of postoperative pain, opioid consumption, and related side effects such as nausea and vomiting. In this study we emphasis on modern enhanced recovery after surgery (ERAS) programme and utilize multimodal analgesic regimens to minimize Intra-operative and postoperative pain by comparing the effect of External oblique intercostal plane block vs Modified Thoracoabdominal nerves block through perichondrial approach.  
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