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CTRI Number  CTRI/2023/09/057794 [Registered on: 18/09/2023] Trial Registered Prospectively
Last Modified On: 20/09/2023
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   The effectiveness of pain relief after Laparoscopic surgery using a modified abdominal plane block compared to injecting local anesthetic at the port site . 
Scientific Title of Study   POST OPERATIVE ANALGESIC EFFICACY OF MODIFIED THORACO ABDOMINAL PLANE BLOCK VS LOCAL ANESTHETIC INFILTRATION AT PORT SITE 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 MADHU GUPTA 
Designation  PROFESSOR, DEPARTMENT OF ANAESTHESIOLOGY 
Affiliation  ESI-PGIMSR MODEL HOSPITAL, NEW DELHI 
Address  Room no 13 ,3rd FLOOR OT COMPLEX ESI-PGIMSR MODEL HOSPITAL,
BASAIDARAPUR, NEW DELHI West DELHI
West
DELHI
110015
India 
Phone  9873581030  
Fax    
Email  madhugupta2602@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR MADHU GUPTA 
Designation  PROFESSOR, DEPARTMENT OF ANAESTHESIOLOGY 
Affiliation  ESI-PGIMSR MODEL HOSPITAL, NEW DELHI 
Address  Room 19 ,3rd FLOOR OT COMPLEX ESI-PGIMSR MODEL HOSPITAL
BASAIDARAPUR, NEW DELHI West DELHI
West
DELHI
110015
India 
Phone  9873581030  
Fax    
Email  madhugupta2602@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr HEMANT SINGH 
Designation  PG JUNIOR RESIDENT 
Affiliation  ESI-PGIMSR MODEL HOSPITAL, NEW DELH 
Address  ROOM 16 ,1st Floor ESI- PGIMSR MODEL HOSPITAL, I
BASAIDARAPUR, NEW DELHI West DELHI 110015
West
DELHI
110015
India 
Phone  9871108915  
Fax    
Email  Hmnt8808@gmail.com  
 
Source of Monetary or Material Support  
ESI postgraduate Institute of medical sciences and research, New Delhi 
 
Primary Sponsor  
Name  ESI post graduate Institute of medical sciences and research New Delhi 
Address  BASAIDARAPUR RING ROAD NEW DELHI 110015 
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 
Dr Hemant Singh  ESIC hospital basaidarapur  Room no 2218 2nd floor OT department of anaesthesia ESIC PGIMSR basaidarapur ring road
West
DELHI 		 9871108915

hmnt8808@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee - employees, State insurance Corporation  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Local anesthetic(LA) infiltration at incision sites  Patients in the L group will receive 20ml of 0.25% bupivacaine infiltration at the incision sites subcutaneously after negative aspiration of blood. 
Intervention  Modified thoracoabdominal plane block  After suturing the incision sites, patients in the M group will get bilateral Ultrasound guided MTAPA block: After a negative blood or fluid aspiration, 20 ml of 0.25% bupivacaine will be administered posterior to the 10th costal cartilage between muscle and cartilage on both sides.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients scheduled for elective laparoscopic cholecystectomy.
Age - 18 years to 60 years
American Society of Anesthesiologists (ASA) physical status classification I-II 
 
ExclusionCriteria 
Details  Known allergy to local anesthetic agent (bupivacaine)
infection at the injection site
history of abdominal surgery
pregnancy  
 
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 compare the requirement of rescue analgesic IV Fentanyl in both groups for 24 hours.  Immediate post op
30 min post op
1hr post op
2hr post op
4 hr post op
6hr post op
8hr post op
12 hr post op
24 hr post op 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the requirement of rescue antiemetic IV metoclopramide in both the groups for 24 hours.
To compare the hemodynamics in both the groups for 24 hours. 		 Immediate post op
30 min post op
1hr post op
2hr post op
4 hr post op
6hr post op
8hr post op
12 hr post op
24 hr post op 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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/ Phase 4 
Date of First Enrollment (India)   19/10/2023 
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
Modification(s)  

Aim of study is to compare analgesic effectiveness of Modified thoracoabdominal nerve block via perichondrial approach(MTAPA) vs LA infiltration at port site in elective laparoscopic cholecystectomy surgeries. 


Seventy  patients  will be enrolled for this study after inclusion and exclusion criteria.  They will be allocated to one of the two groups


Written informed consent will be taken from the patients.

Group L = patients will receive local anesthetic at incision sites                                                                  

Group M = patients will receive ultrasound guided MTAPA block after suturing incision sites


Following the end of the surgical operation, MTAPA/LA infiltration will be performed before reversing the patient’s from general anaesthesia. patient will be transferred to the postoperative recovery room(PACU).

Patients in both groups will receive i.v. Paracetamol 1gm 8hourly 

                                                                Diclofenac 75mg if NRS>3 

                                                                 Fentanyl as rescue analgesic

Patient will be assessed for pain by anaesthesia resident blinded to group allocation at Â,½, 2, 4, 6, 8,12 and 24hrs in recovery room.

The severity of pain at rest and movement will be assessed using   Numeric Pain Scale (NRS).

Total postoperative Analgesic consumption   - (PCA fentanyl) will be recorded , Total requirement of rescue analgesic (fentanyl) for NRS >5, will be recorded.

 
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