| CTRI Number |
CTRI/2026/02/104784 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study to evaluate which dose of IV lidocaine gives better pain control after laparoscopic cholecystectomy. |
|
Scientific Title of Study
|
A Randomised Comparative Study of Two Different Doses of Intravenous Lidocaine for Post Operative Analgesia in Patients undergoing Laparoscopic Cholecystectomy under General Anasthesia at SMS Medical College Jaipur |
| 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 Siddharth Sharma |
| Designation |
Senior professor |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesiology Operation Theatre 2 SMS MEDICAL
COLLEGE AND HOSPITAL JAIPUR RAJASTHAN
Jaipur
RAJASTHAN
302004
India
Department of Anaesthesiology Operation Theatre 2 SMS MEDICAL
COLLEGE AND HOSPITAL JAIPUR RAJASTHAN
Jaipur
RAJASTHAN
302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829950020 |
| Fax |
|
| Email |
drsiddharthasharma@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Astha Abusaria |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical College , Jaipur |
| Address |
Department of Anaesthesiology Operation Theatre 2 SMS MEDICAL
COLLEGE AND HOSPITAL JAIPUR RAJASTHAN
Jaipur
RAJASTHAN
302004
India
Jaipur
RAJASTHAN
302004
India |
| Phone |
8952075051 |
| Fax |
|
| Email |
asthaabusaria18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Siddharth Sharma |
| Designation |
Senior professor |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesiology Operation Theatre 2 SMS MEDICAL
COLLEGE AND HOSPITAL JAIPUR RAJASTHAN
Jaipur
RAJASTHAN
302004
India
Department of Anaesthesiology Operation Theatre 2 SMS MEDICAL
COLLEGE AND HOSPITAL JAIPUR RAJASTHAN
Jaipur
RAJASTHAN
302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829950020 |
| Fax |
|
| Email |
drsiddharthasharma@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology SMS MEDICAL COLLEGE AND HOSPITAL JAIPUR
RAJASTHAN INDIA -302004
|
|
|
Primary Sponsor
|
| Name |
SMS MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Anaesthesiology SMS MEDICAL COLLEGE AND
HOSPITAL JAIPUR RAJASTHAN 302004 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Siddharth Sharma |
SMS MEDICAL COLLEGE AND HOSPITAL |
Department of
Anaesthesiology
operation theater 2
Jaipur RAJASTHAN
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
98299 50020
drsiddharthasharma@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical College And Attached Hospitals,Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, , (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lignocaine |
Post operative analgesia in patients undergoing laparoscopic cholecystectomy by use of two different doses of intravenous lignocaine infusion in general anaesthesia |
| Comparator Agent |
Lignocaine with infusion rate 1.5mg/kg/hr |
Post operative analgesia in patients undergoing laparoscopic cholecystectomy by use of two different doses of intravenous lignocaine infusion in general anasthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients giving consent for the participation Patients undergoing laparoscopic cholecystectomy
Patients belonging to American Society of Anaesthesiologists (ASA) class I and Il |
|
| ExclusionCriteria |
| Details |
Patients with severe cardiac, respiratory, hepatic,renal or endocrine disease
Patient with electrolyte disorder
Pregnant women and Lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
. Mean time to first rescue analgesia in minutes
• Mean NRS score.
• Mean of total analgesic consumption.
|
Immediately after surgery, at 30min then every 4 hourly till 12 hrs and then every 6 hrly till 24 hrs
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean hemodynamic parameters (HR, SBP, DBP, MAP and SpO2).
Proportion of cases with side effects/complications. |
Baseline, 5min , 10min , 15 min , 30min , 1hr, 2hr ,6hr, 8hr,12hr |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
10/03/2026 |
| 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="0"
Months="2"
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 - NO
|
|
Brief Summary
|
To compare two different dose of lidocaine infusion in patient undergoing laparoscopic cholecystectomy under general anasthesia with regard to post operative analgesia by using NRS SCORE and to determine the changes in hemodynamic parameters (HR, SBP, DBP, MAP and SPO2) between two groups . |