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CTRI Number  CTRI/2024/01/061302 [Registered on: 09/01/2024] Trial Registered Prospectively
Last Modified On: 18/12/2023
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   A Clinical Trial To Study Postoperative Pain By Comparing Block Versus Infiltration Technique In Laparoscopic Cholecystectomy Patients. 
Scientific Title of Study   A Prospective Randomized Controlled Study Based On Comparison Of Postoperative Analgesia Between Ultrasound Guided Five Point Transverse Abdominis + Rectus Sheath Plane Block Versus Conventional Port Site Infiltration 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  Ranjitha 
Designation  DNB Anaesthesia Resident 
Affiliation  Sri Narayani Hospital And Research Centre 
Address  Department Of Anaesthesiology Sri Narayani Hospital And Research Centre Vellore-632055 Tamil Nadu

Vellore
TAMIL NADU
632055
India 
Phone  9698599624  
Fax    
Email  ranjithan303@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Kiran Kuruvilla George 
Designation  Consultant Anaesthetist 
Affiliation  Sri Narayani Hospital And Research Centre 
Address  Department Of Anaesthesiology Sri Narayani Hospital And Research Centre Vellore-632055 Tamil Nadu
Sri Narayani Hospital and Research Centre. Vellore
Vellore
TAMIL NADU
632055
India 
Phone  9698599624  
Fax    
Email  kirangeorge_k2g@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Ranjitha 
Designation  DNB Anaesthesia Resident 
Affiliation  Sri Narayani Hospital And Research Centre 
Address  Department Of Anaesthesiology Sri Narayani Hospital And Research Centre Vellore-632055 Tamil Nadu

Vellore
TAMIL NADU
632055
India 
Phone  9698599624  
Fax    
Email  ranjithan303@gmail.com  
 
Source of Monetary or Material Support  
Sri Narayani Hospital And Research Centre 
 
Primary Sponsor  
Name  Sri Narayani Hospital And Research Centre 
Address  Department Of Anaesthesiology Sri Narayani Hospial And Research Centre Vellore-632055 Tamil Nadu 
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 
Ranjitha N  Sri Narayani Hospital and Research Centre  Department of Anaesthesiology, Sri Narayani Hospital and Research Centre A and C block operation Theatres
Vellore
TAMIL NADU 		 9698599624

ranjithan303@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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  Port Site Infiltration   Port Site Infiltration with 0.5percent Ropivacaine 20 ml with Dexamethasone 2ml In Laparoscopic Cholecystectomy Patients. 
Intervention  Ultrasound Guided Transverse abdominis plus Rectus sheath Plane Block  Ultrasound Guided Five Point Transverse Abdominis + Rectus Sheath Plane with 0.2percent Ropivacaine 50ml with Dexamethasone 2ml Laparoscopic Cholecystectomy Patients  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  American Society Of Anaesthesiology 1 and 2 
 
ExclusionCriteria 
Details  Patient Refusal American Society Of Anaesthesiologists Morethan 3
Allergic To Amide Local Anesthetics Or Medications Included In Study
Infection At The Needle Insertion Site
Pregnant Women
Body Mass Index Morethan 35
Drug Abusers

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The Assessment of Duration of Post Operative Analgesia  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Total Analgesic Required in 24 hours Intraoperative and Postoperative Opioid Consumption  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)   12/01/2024 
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 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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ranjithan303@gmail.com].

  6. For how long will this data be available start date provided 06-05-2024 and end date provided 28-11-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This study is a prospective randomized ,single blind , controlled study based on comparison post operative analgesia after elective laparoscopic cholecytectomy cases by ultrasound  guided five point transverse abdominis plus rectus sheath plane block with 0.2percent Ropivacaine 50ml with Dexamethasone 2ml  versus conventional port site infiltration with 0.5percent Ropivacaine 20 ml with Dexamethasone 2ml . The primary outcome measure will be to assess the duration of post operative analgesia in the immediate postoperative period that is with in 24hrs .The secondary outcome measures were perioperative opioid consumption in the form Fentanyl or Tramadol and time of first dose of rescue analgesia , total analgesia requirements in 24 hrs. 
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