FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/068344 [Registered on: 05/06/2024] Trial Registered Prospectively
Last Modified On: 26/05/2024
Post Graduate Thesis  Yes 
Type of Trial  PMS 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of USG guided Serratous anterior muscle block vs Transverse abdominis block in management post operative pain following laparoscopic cholecystectomy 
Scientific Title of Study   Comparison between USG guided Unilateral Serratus anterior plane block versus Unilateral Transversus abdominis plane block for postoperative analgesia in patients undergoing Laparoscopic Cholecystectomy: A open label randomized control 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  Bhagyashree Solanki 
Designation  PG Student 
Affiliation  Department of Anaesthesiology, Dr SN medical college Jodhpur 
Address  Dr.SN MEDICAL COLLEGE, Department of anaesthesiology sector-D, Shastri nagar, jodhpur rajasthan
Subhash Nagar phase 2, near AIIMS road
Jodhpur
RAJASTHAN
342003
India 
Phone  9079196379  
Fax    
Email  bssolanki19933@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chanda Khatri 
Designation  Professor 
Affiliation   
Address  Dr.SN MEDICAL COLLEGE, Department of anaesthesiology sector-D, Shastri nagar, jodhpur rajasthan


RAJASTHAN
342003
India 
Phone  9079196379  
Fax    
Email  chandakhatri90@gmail.com  
 
Details of Contact Person
Public Query  
Name  Bhagyashree Solanki 
Designation  PG Student 
Affiliation  Department of Anaesthesiology, Dr SN medical college Jodhpur 
Address  Dr.SN MEDICAL COLLEGE, Department of anaesthesiology sector-D, Shastri nagar, jodhpur rajasthan
Subhash Nagar phase 2, near AIIMS road

RAJASTHAN
342003
India 
Phone  9079196379  
Fax    
Email  bssolanki19933@gmail.com  
 
Source of Monetary or Material Support  
Dr SN medical College, Jodhpur (342003), Rajasthan, India  
 
Primary Sponsor  
Name  Dr.SN MEDICAL COLLEGE, Jodhpur 
Address  Residency Rd, Sector D, Shastri Nagar, jodhpur, Rajasthan 342003 
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 Bhagyashree Solanki  Dr SN medical College  Dept of Anaesthesiology, Dr SN medical COllege, Resideny Rd, sector-D, Shastri nagar, jodhpur rajasthan
Jodhpur
RAJASTHAN 		 9079196379

bssolanki19933@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr SNMC Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K807||Calculus of gallbladder and bile duct without cholecystitis, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  unilateral serratus anterior plane block  USG guided SAP block will be placed following laparoscopic Cholecystectomy 
Intervention  usg guided unilateral transversus abdominis plane block   USG guided TAP block will be placed following laparoscopic Cholecystectomy 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA Grade 1&2
BMI 18.5-22.9
Patient underwent elective laproscopic cholecystectomy under GA for duration of surgery less than 120 minutes after obtaining written informed consent 
 
ExclusionCriteria 
Details  allergy to local anasthetic drug
patient with opiod dependency
puncture site infection
surgery time more than 120 minutes
surgeries done in emergency settings 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the postoperative pain upto 24 hours after laproscopic cholecystectomy with the use of visual
analogue score 		 Base line and than 6, 12, 18, 24 hours  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the time of the first dose of rescue analgesia for the first 24 hours postoperatively
 		 first 24 hours 

total tramadol consuption for the first 24 hours postoperatively
 		 first 24 hours 
to compare the hemodynamic parameters (systolic bp, diastolic bp ,MAP, Heart rate , spo2)  first 24 hours  
to compare the complications (nausea,vomiting, pain at the injection site)  first 24 hours  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/07/2024 
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 study is to compare the efficacy of USG guided Transversus Abdominis plane block Vs USG guided Serratus Anterior plane block in terms of managing postoperative pain following Laparoscopic Cholecystectomy.  the Research hypothesis is that, the USG guided Unilateral Transversus abdominis plane block is more effective than USG guided Unilateral Serratus anterior plane block in managing postoperative pain after laparoscopic cholecystectomy. 
Close