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CTRI Number  CTRI/2018/05/013557 [Registered on: 01/05/2018] Trial Registered Prospectively
Last Modified On: 23/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Pain relief after laparoscopic procedure 
Scientific Title of Study   Comparative study of intraperitoneal instillation of levobupivacaine (0.25%) plus dexmedetomidine versus ropicacaine (0.25%) plus dexmedetomidine for post operative analgesia in patients undergoing 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 Joginder Pal 
Designation  Professor 
Affiliation  Govt Medical College Amritsar 
Address  Department of Ananesthesia Govt Medical College, Amritsar

Amritsar
PUNJAB
143001
India 
Phone    
Fax    
Email  jpattri12@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Kulwinder Pal Singh 
Designation  Junior Resident 
Affiliation  Govt Medical College Amritsar 
Address  Department of Ananesthesia Govt Medical College, Amritsar

Amritsar
PUNJAB
143001
India 
Phone    
Fax    
Email  drkulwinder@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kulwinder Pal Singh 
Designation  Junior Resident 
Affiliation  Govt Medical College Amritsar 
Address  Department of Ananesthesia Govt Medical College, Amritsar


PUNJAB
143001
India 
Phone    
Fax    
Email  drkulwinder@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, Guru Nanak Dev Hospital Majitha Road, Govt Medical College Amritsar 
 
Primary Sponsor  
Name  Govt Medical College Amritsar 
Address  Department of Anaesthesia, Govt Medical College, Amritsar 
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 Joginder Pal  Govt Medical College Amritsar  Department of Anaesthesia, Guru Nanak Dev Hospital, Majitha Road
Amritsar
PUNJAB 		 9501025275

jpattri12@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  ASA Grade I and II, (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ropivacaine plus dexmedetomidine  to compare and evaluate the effects of intraperitoneal instillation of 0.25% levobupivacaine plus dexmedetomidine versus 0.25% ropivacaine plus dexmedetomidine for postoperative analgesia in patients undergoing laparoscopic cholecystectomy 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. All patients of 18 - 65 years of either sex
2. All ASA grade I and II admitted in the Surgery department.
3. Patients posted for laparoscopic cholecystectomy surgery under general anaesthesia 
 
ExclusionCriteria 
Details  Pregnant and lactating women
Patients with morbid obesity i.e. BMI of 35 Kg/m2.
Patients on psychotropic or adrenergic drugs
Refusal by patient to enlist in study
● Patients with chronic pain syndrome.
● History of previous abdominal surgery.
● Patients in whom conversion to open cholecystectomy is done for any reason.
Allergy to study drug.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To study the post-operative analgesic effect of 0.25% levobupivacaine plus dexmedetomidine with 0.25% ropivacaine plus dexmedetomidine with Normal Saline (Control Group) following intra-peritoneal instillation in laparoscopic cholecystectomy.
2. Duration of postoperative analgesia (hours).
3. To assess the need of rescue analgesics in post-operative period in all the groups.
 		 8 hours
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Haemodynamic changes.
2. Any side effects or complications (confusion, dizziness, auditory and visual disturbances, convulsions, hypertension and cardiovascular collapse, tachycardia, arrthymias and respiratory depression).

 		 48 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 1 
Date of First Enrollment (India)   01/05/2018 
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="1"
Days="1" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Non yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The aim of the present study is to compare and evaluate the effects of intraperitoneal instillation of 0.25% levobupivacaine plus dexmedetomidine versus 0.25% ropivacaine plus dexmedetomidine for postoperative analgesia in patients undergoing laparoscopic cholecystectomy. The aim will be accomplished by carrying out a study on 90 patients randomly divided into 3 groups of 30 each in the age group of 18-65 years, of either sex, of ASA grade I, II and III selected for laparoscopic cholecystectomy after proper preanaesthetic check up. Postoperative analgesia will be achieved in group L by using 40 ml of 0.25% levobupivacaine plus dexmedetomidine @ 1µgm per Kg Body weight and in group R by using 40 ml of 0.25% ropivacaine plus dexmedetomidine @ 1µgm per Kg Body weight and Group C will be given 40 ml Normal Saline.  The three groups will be compared with respect to haemodynamic changes, onset and regression of analgesia, requirement of rescue analgesia, side effects and complications with the help of scale discussed in plan. The observation will be recorded and the results will be statistically analysed.

 
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