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CTRI Number  CTRI/2024/10/075335 [Registered on: 15/10/2024] Trial Registered Prospectively
Last Modified On: 13/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Intraperitoneal instillation of Bupivacaine with Magnesium sulphate versus Intravenous analgesics drugs for post operative pain relief after Laparoscopic cholecystectomy. 
Scientific Title of Study   Comparison of Intraperitoneal instillation of Bupivacaine with Magnesium sulphate versus Intravenous analgesics drugs for post operative pain relief after Laparoscopic cholecystectomy - A Randomized controlled 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 Kajal 
Designation  Junior resident  
Affiliation  Heritage institute of medical sciences 
Address  Heritage institute of medical sciences, NTS building 505 ,NH-2 , bhadwar ,varanasi

Varanasi
UTTAR PRADESH
221311
India 
Phone  7988379093  
Fax    
Email  ranakajal0000@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pushkar Ranjan  
Designation  Professor 
Affiliation  Heritage institute of medical sciences 
Address  Heritage institute of medical sciences, NTS building ,NH-2 , bhadwar ,varanasi

Varanasi
UTTAR PRADESH
221311
India 
Phone  9415986684  
Fax    
Email  pushkarranjanbhu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kajal 
Designation  Junior resident  
Affiliation  Heritage institute of medical sciences 
Address  Heritage institute of medical sciences, NTS building 505 ,NH-2 , bhadwar ,varanasi

Varanasi
UTTAR PRADESH
221311
India 
Phone  7988379093  
Fax    
Email  ranakajal0000@gmail.com  
 
Source of Monetary or Material Support  
Heritage institute of medical sciences , varanasi, uttar pradesh pincode-221311,India  
 
Primary Sponsor  
Name  HERITAGE INSTITUTE OF MEDICAL SCIENCES  
Address  Heritage institute of medical sciences ,Varanasi 221311,Uttar pradesh ,India pincode-221311 
Type of Sponsor  Private 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 Kajal  Heritage institute of medical sciences  Department of anaesthesiology, Heritage institute of medical sciences
Varanasi
UTTAR PRADESH 		 7988379093

ranakajal0000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
HIMS ETHICS COMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intraperitoneal instillation of Bupivacaine with Magnesium sulphate   At the end of gall bladder removal, 0.25% of bupivacaine +500mg magnesium sulphate 20ml will be instilled in the gallbladder bed in right trendelenburg position. the volume of 6ml will be infiltrated through the abdominal wall around the midline port site and 4ml at the lateral port site. 
Comparator Agent  INTRAVENOUS ANALGESIC AGENTS  At the end of gall bladder removal, Intravenous paracetamol (15ml/kg) followed by Inj. diclofenac (1-1.5mg/kg) 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Inclusion Criteria

1. Patients undergoing elective laparoscopic cholecystectomy,
2. Patients of ASA grade 1 and 2 and
3. Patients aged between 20 to 60 years 
 
ExclusionCriteria 
Details  Exclusion Criteria

1. Patient who will give negative informed consent .
2. Patients with allergy to the study drugs (MgSO4, Bupivacaine ,Paracetamol)
3. Chronic alcoholics,
4. Patients with heart block or renal failure .
5. Patients with peritoneal drain after surgery.
6. Patients treated with calcium channel blockers
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To compare post operative pain in laparoscopic cholecystectomy patients who will receive intravenous (IV) analgesics drugs versus those who will receive intraperitoneal Bupivacaine with Magnesium sulphate.
 		 AT 30 mins, 1 hour, 2 hour, 3 hour,6 hour, 12hour, 24hour
 
 
Secondary Outcome  
Outcome  TimePoints 
To assess changes in hemodynamic response and any adverse effects.  30 mins, 1hour, 2hour,3hour, 6 hour, 12 hour ,24 hour 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   24/10/2024 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ranakajal0000@gmail.com].

  6. For how long will this data be available start date provided 26-07-2024 and end date provided 01-08-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   In this study , 52 patients aged between 20yrs to 60 yrs undergoing laparoscopic cholecystectomy will be randomly divided into 2 groups for comparions of post -op pain relief after laparoscopic cholecystectomy . in one group patient will be given intraperitoneal instillation of bupivacaine with magnesium sulphate ,while in other group patient will receive intravenous analgesic agents for post operative pain.
Measuring indicator : NRS NUMERIC RATING SCALE
RAMSAY SEDATION SCALE 
TIME FOR NEED FOR FIRST RESCUE ANALGESIA
 
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