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CTRI Number  CTRI/2020/06/025839 [Registered on: 12/06/2020] Trial Registered Prospectively
Last Modified On: 27/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of lignocaine infusion and pain relief 
Scientific Title of Study   Effect of intravenous lignocaine on perioperative opioid consumption for pain and intraoperative hemodynamics in laparoscopic surgery 
Trial Acronym  LIHOC 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prasanna vadhanan 
Designation  Professor 
Affiliation  Vinayaka Missions Research Foundation 
Address  Department of Anaesthesiology Vinayaka Missions Medical College, Karaikal

Karaikal
PONDICHERRY
609609
India 
Phone    
Fax    
Email  vadhanan.prasanna@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Arun Dev 
Designation  Resident 
Affiliation  Vinayaka Missions Research Foundation 
Address  Department of Anaesthesiology Vinayaka Missions Medical College, Karaikal

Karaikal
PONDICHERRY
609609
India 
Phone    
Fax    
Email  dr.arundev646@gmail.com  
 
Details of Contact Person
Public Query  
Name  Arun Dev 
Designation  Resident 
Affiliation  Vinayaka Missions Research Foundation 
Address  Department of Anaesthesiology Vinayaka Missions Medical College, Karaikal

Karaikal
PONDICHERRY
609609
India 
Phone    
Fax    
Email  dr.arundev646@gmail.com  
 
Source of Monetary or Material Support  
Vinayaka Missions research foundation 
 
Primary Sponsor  
Name  Vinayaka Missions Research Foundation 
Address  Vinayaka missions medical college, Karaikal 609609 
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 
Prof Prasanna vadhanan  Vinayaka Misisons medical college  Department of Anaesthesiology Room No PACU2 Department of Anaesthesiology Vinayaka Missions Medical College Karaikal
Karaikal
PONDICHERRY 		 9486489690

vadhanan.prasanna@gmail.com 
 
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  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K811||Chronic cholecystitis, (2) ICD-10 Condition: K36||Other appendicitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine  1ug/kg bolus followed by 0.5ug/kg/hour infusion 
Intervention  Lignocaine  Intravenous lignocaine 1.5mg/kg bolus followed by an infusion of 1.5mg/kg/hour during the intraoperative period 
Comparator Agent  Normal saline  1.5ml/kg bolus followed by 10ml/hour infusion 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  American society of Anesthesiologists physical status 1 and 2, BMI 22-30kg/m2,  
 
ExclusionCriteria 
Details  ASA physical status 3 and 4
Emergency surgery, significant cardiac, respiratory and neurological illness, patients on chronic antiarrythmic drugs, psychotropic drugs, allergy to local anesthetics 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
post operative VAS score  0 min, 15 min, 30 min, 1 hour, 2 hour, 6 hour,12 hour, 24 hour 
 
Secondary Outcome  
Outcome  TimePoints 
Analgesia consumption (inj diclofenac, inj tramadol)  Hourly till 6 hours, 4th hourly till 24 hours 
intraoperative heartrate and blood pressure  every 5 minutes throughout surgery 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/06/2020 
Date of Study Completion (India) 23/01/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Ninety adult patients of either sex undergoing elective laparoscopic surgeries for appendicectomy or cholecystectomy will be recruited for this trial. Informed written consent will be obtained after satisfying inclusion criteria. They will be randomised into three groups of thirty each, all groups general anesthesia using standard protocol 9propofol 2mg/kg, fentanyl 0.002mg/kg, vecuronium 0.1mg/kg followed by endotracheal intubation; maintenance with 50:50 oxygen, nitrousoxide and sevoflurane 1.5MAC). Group L will receive 1.5mg/kg bolus folllowed by 1.5mg/kg/hour infusion of lignocaine, group P will receive normal saline infusion and Group D will receive dexmedetomidine bolus 1ug/kg followed by 0.5ug/kg/hour infusion during the intraoperative period. All infusions will be stopped during skin closure and following parameters will be observed : intraoperative pulse rate, blood pressure, post operative VAS scores and analgesia consumption during first 24 hours. statistical analysis will be done using appropriate tests. 
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