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CTRI Number  CTRI/2022/07/044455 [Registered on: 28/07/2022] Trial Registered Prospectively
Last Modified On: 27/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the effects of two drug groups, levobupivacaine and dexmedetomidine with ropivacaine and dexmedetomidine for intraperitoneal injection after laparoscopic gall bladder removal. 
Scientific Title of Study   Evaluation of postoperative analgesic effect of intraperitoneal instillation of 0.125% levobupivacaine + 1 μg/kg dexmedetomidine or 0.2% ropivacaine +1 μg/kg dexmedetomidine after laparoscopic cholecystectomy. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vinod Kumar Saini 
Designation  Postgraduate resident 
Affiliation  JLN Medical collage Ajmer 
Address  Department of anaesthesiology New Ot JLN medical collage Ajmer RAJASTHAN

Ajmer
RAJASTHAN
305001
India 
Phone  09929628371  
Fax    
Email  vinodsn332@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neena Jain 
Designation  Senior professor 
Affiliation  JLN Medical collage Ajmer 
Address  Department of anaesthesiology New Ot JLN medical collage Ajmer RAJASTHAN

Ajmer
RAJASTHAN
305001
India 
Phone  9414008666  
Fax    
Email  drneenaj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Neena Jain 
Designation  Senior professor 
Affiliation  JLN Medical collage Ajmer 
Address  Department of anaesthesiology New Ot JLN medical collage Ajmer RAJASTHAN

Ajmer
RAJASTHAN
305001
India 
Phone  9414008666  
Fax    
Email  drneenaj@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesia, new Ot, JLN Medical College Ajmer 
 
Primary Sponsor  
Name  JLN medical college Ajmer 
Address  Department of anaesthesiology New Ot JLN medical collage Ajmer RAJASTHAN  
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 Vinod kumar saini  JLN medical college Ajmer   Department of anaesthesiology New Ot JLN medical collage Ajmer RAJASTHAN
Ajmer
RAJASTHAN 		 09929628371

vinodsn332@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITEE, JLN MEDICAL COLLEGE, AJMER  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 
Intervention  INTRAPERITONEAL INSTILLATION of 0.125% LEVOBUPIVACAINE PLUS 1microgram/kg DEXMEDETOMIDINE   intraperitoneal instillation of 0.125% levobupivacaine 40ml + dexmedetomidine 1microgram/kg making the total volume of 40 ml was done. All patients will receive infiltration of 24 mL of 0.125% levobupivacaine at trocars insertion site, being 4mL in the umbilical incision, 4mL in the epigastric incision and 4mL in both working portals after gall bladder removal to evaluate post operative analgesic effect for 24 hours. 
Comparator Agent  INTRAPERITONEAL INSTILLATION OF 0.2% ROPIVACAINE plus 1microgram/Kg DEXMEDETOMIDINE AFTER LAPAROSCOPIC CHOLECYSTECTOMY  intraperitoneal instillation of 0.2 % ropivacaine 40ml + dexmedetomidine 1microgram/kg making the total volume of 40 ml. and All patients will receive infiltration of 24mL of 0.2% ropivacaine at trocars insertion site, being 4mL in the umbilical incision, 4mL in the epigastric incision and 4mL in both working portals after gall bladder removal to evaluate post operative analgesic effect for 24 hours. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient belonging to ASA I and II
2.Gall bladder calculi. 
 
ExclusionCriteria 
Details  1. ASA grade III and above.
2. age <18 years and >60 years.
3. patients with severe systemic disease like IDDM, uncontrolled hypertension, kidney and liver disease, severe respiratory disease.
4. seizure disorder.
5. CAD or recent history of MI.
6. Anticipated difficult intubation.
7. body weight >100kg or obese.
8. pregnant and lactating women.
9. patient of psychiatric disorder and sleep disorders.
10.hypersensitivity to study drugs.
11.conversion of laparoscopic cholecystectomy to open cholecystectomy.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Duration of post operative analgesia.  1. Duration of post operative analgesia at 0,1,2,4,6,8,10,12,24 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
1.total rescue analgesic required in 24 hours.
2. hemodyanamic changes.
3. side effects like hypotension,bradycardia,postoperative nausea and vomiting,sedation,respiratory depression,pruritus and any other. 		 1. Duration of post operative analgesia at 0,1,2,4,6,8,10,12,24 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   N/A 
Date of First Enrollment (India)   05/08/2022 
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   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   We aimed to conduct a study to evaluate postoperative analgesic efficacy of intraperitoneal instillation of levobupivacaine + dexmedetomidine or ropivacaine + dexmedetomidine in patients undergoing laparoscopic cholecystectomy.
 
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