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CTRI Number  CTRI/2024/01/061269 [Registered on: 09/01/2024] Trial Registered Prospectively
Last Modified On: 03/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Abdominal nerve block through ultrasound scanning and local anaesthetic drug deposition inside abdomen through abdominal portsite is compared for providing postoperative pain relief in patients undergoing laparoscopic gall bladder stone surgeries. 
Scientific Title of Study   A comparison between ultrasound guided bilateral subcostal transversus abdominis plane block versus intraperitoneal instillation of local anaesthetic for postoperative analgesia in laparoscopic cholecystectomy patients: A prospective randomised comparative clinical 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 AMRUTHA P 
Designation  Post graduate resident 
Affiliation  Medical College and SSG Hospital Baroda 
Address  Medical College Baroda Vinoba Bhave Road Anandpura Vadodara

Vadodara
GUJARAT
390001
India 
Phone    
Fax    
Email  ammulyf@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr JAYESH C VASAVA 
Designation  Profesor and Head of Department 
Affiliation  Medical College Baroda 
Address  Medical College Baroda Vinoba Bhave Road Anandpura Vadodara

Vadodara
GUJARAT
390001
India 
Phone  9998730955  
Fax    
Email  jc.vasava@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Dr JAYESH C VASAVA 
Designation  Professor and Head of Department 
Affiliation  Medical College Baroda 
Address  Medical College Baroda Vinoba Bhave Road Anandpura Vadodara

Vadodara
GUJARAT
390001
India 
Phone  9998730955  
Fax    
Email  jc.vasava@yahoo.in  
 
Source of Monetary or Material Support  
Baroda Medical College Vadodara Gujarat 390001 
 
Primary Sponsor  
Name  Medical College Baroda 
Address  Medical College Baroda Vinoba Bhave Road Anandpura Vadodara 
Type of Sponsor  Government 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 Amrutha P  SSG hospital Medical College Baroda  Ward D1 COT, OT Block, second floor, Department of General surgery, Baroda Medical College, Vadodara, Gujarat 390001
Vadodara
GUJARAT 		 6354744892

ammulyf@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Biomedical and Health Research Medical College and SSG Hospital Baroda  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  Intraperitoneal instillation of local anaesthetic solution  30 cc, 0.25% of Inj Bupivacaine local with 8mg Dexamethasone is administered intraperitoneally under vision after trocar insertion and just after the creation of pneumoperitoneum, through the portsite before the start of the surgery. 
Intervention  Ultrasound guided bilateral subcostal Transversus Abdominis Plane block  The patient is placed in the supine position. After induction of general anaesthesia, skin over subcostal region is cleaned with 5% Povidone Iodine solution and then draping is done. A 6 to 8 Hertz linear ultrasound probe of SSMED Ultrasound machine (DIGI 1100 CD) is positioned perpendicular to the abdominal wall, parallel to the costal margin, over the mid axillary line and the three muscle layers are identified alongwith their fascial layers. (External oblique, Internal oblique and Transversus abdominis) The needle is inserted in-plane to the ultrasound beam from near the xiphoid process and the drug is deposited just below the fascia of internal oblique muscle so as to depress the transverses abdominis muscle below it. Under ultrasound guidance bilateral subcostal transversus abdominis plane (TAP) block is given preoperatively before starting the surgery using 30 cc of 0.25% Inj Bupivacaine local and 8mg Dexamethasone. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  ASA grade I II III
BMI less than or equal to 30 kg per meter square
 
 
ExclusionCriteria 
Details  Patients who refused consent to be part of clinical study
Patients with allergy to local anaesthetics
Infection at the site of injection
Coagulopathy
Duration of surgery for more than 3 hours
Laparoscopic surgeries that gets converted into open cholecystectomy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the duration of postoperative analgesia between two groups  Time required for administration of first postoperative rescue analgesia in VAS score more than 4 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor intraoperative hemodynamic stability  1min, 5min, 10min, 30min, 60min, 90min, 120min, 150min, 180min 
To assess VAS score postoperatively  2hours, 4 hours, 6hours, 8hours, 12hours, 24hours 
Total amount of postopeative analgesia administered  24 hours postoperatively 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   15/01/2024 
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 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 aim of our study is to evaluate and compare the efficacy of postoperative analgesia provided by Transversus Abdominis Plane block and intraperitoneal instillation of local anaesthetic solution in patients who are undergoing laparoscopic cholecystectomy. 80 patients belonging to the age group 18 to 70 years with ASA status I, II or III are randomly selected into two groups. Group T are those patients who received Ultrasound guided bilateral subcostal Transversus Abdominis plane block using 30mL of 0.25% Bupivacaine local solution just after the induction of general anaesthesia and Group L are those who received intraperitoneal instillation of 30mL of 0.25% of Bupivacaine local solution under vision just after trocar insertion and before the start of the surgery. Intraoperative hemodynamic stability is monitored among the two groups by monitoring the HR,BP,SpO2 and EtCO2. Postoperatively the time taken for the administration of the first dose of rescue analgesia at VAS >=4 is also noted among the two groups. The total amount of postoperative analgesic requirement in 24 hours time period and the VAS scores at 2,4,6,8, 12 and 24 hours are also compared among the two groups. 
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