| CTRI Number |
CTRI/2025/08/093418 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to compare Intravenous Lignocaine versus Ketamine versus Normal saline on Post operative pain after Abdominal surgeries under General Anaesthesia at SMS Medical College, Jaipur. |
|
Scientific Title of Study
|
A Randomised Controlled Study to Evaluate the Effect of Perioperative Intravenous Lignocaine versus Ketamine versus Normal Saline on Post Operative Pain after Abdominal Surgeries under General Anaesthesia 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 Kanchan Chauhan |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College and Hospital |
| Address |
Department of Anesthesia
SMS Medical college and Hospital
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8107872222 |
| Fax |
|
| Email |
kanchan2371@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ragupathi C |
| Designation |
Second year PG resident |
| Affiliation |
Sawai Man Singh Medical College and Hospital |
| Address |
Department of Anesthesia
Sawai Man Singh Medical college and Hospital
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9698070211 |
| Fax |
|
| Email |
drragu17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kanchan Chauhan |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College and Hospital |
| Address |
Department of Anesthesia
SMS Medical college and Hospital
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8107872222 |
| Fax |
|
| Email |
kanchan2371@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sawai Man Singh Medical college and Hospital, General Surgery OT Complex - 2 |
|
|
Primary Sponsor
|
| Name |
Sawai Man Singh Medical college and hospital |
| Address |
Department of Anesthesia, second floor, Dhanvantri block, SMS medical college and hospital |
| 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 Ragupathi C |
Sawai Man Singh Medical college and Hospital |
General surgery OT complex, Department of anesthesia, Sawai Man Singh medical college and hospital
Jaipur
RAJASTHAN |
9698070211
drragu17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the Ethics committee SMS Medical College and Attached Hospitals |
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 |
| Comparator Agent |
Injection Ketamine |
Patient will receive inj ketamine continuous infusion 0.15mg/kg/hr at the rate of 5ml /hr for 1.5 hours |
| Intervention |
Injection Lignocaine |
Patient will receive inj lignocaine continuous infusion1.5mg/kg/hr at the rate of 5ml/hr for 1.5 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients scheduled for abdominal surgeries under general anaesthesia.
2.Patient willing to give informed written consent.
3.American Society of Anaesthesiologist (ASA) physical status I and II.
4.Duration of surgery upto 120 minutes.
|
|
| ExclusionCriteria |
| Details |
1.Patient who is a part of any other study.
2.Pregnant or breastfeeding patients.
3.Obese
4.Chronic preoperative opioid use or substance abuse and history of chronic pain.
5.Allergy or contraindications to use of study medications such as cardiac, renal, hepatic disease, seizure or other neurological disorder.
6.Patients requiring postoperative mechanical ventilation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess and compare the difference in time to first rescue analgesic administration in first 24 hours postoperatively among the groups.
|
1.To assess and compare the difference in time to first rescue analgesic administration in first 24 hours (1hr, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 10hrs, 12hrs, 18hrs, 24hrs)postoperatively among the groups.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess & compare the difference in mean rescue analgesic consumption in first 24 hours postoperatively among the groups
2.To assess & compare the difference in mean VAS scores in first 24 hours (1hr, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 10hrs, 12hrs, 18hrs, 24hrs) postoperatively among the groups.
3.To assess & compare the difference in mean Ramsay Sedation Score in first 24 hours (1hr, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 10hrs, 12hrs, 18hrs, 24hrs) postoperatively among the groups.
4.To assess & compare the change in Haemodynamic parameters (HEART RATE (bpm), SBP(mm hg), DBP(mm hg) & MAP (mm hg)) from baseline at different time intervals among the groups.
5.To assess & compare the difference in the proportion of cases with side effects ( like tinnitus, numbness, psychomotor disturbances, nausea, vomiting up to 24 hours among the groups.
|
(1hr, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 10hrs, 12hrs, 18hrs, 24hrs) |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
31/08/2025 |
| 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="6"
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
|
This randomized controlled study aimed to evaluate the effectiveness of perioperative intravenous lignocaine and ketamine compared to normal saline in managing postoperative pain following abdominal surgeries under general anaesthesia. Patients were randomly assigned to receive either IV lignocaine, IV ketamine, or normal saline during the perioperative period. Pain intensity was assessed at various postoperative intervals using standardized pain scales, along with measurements of total opioid consumption and time to first rescue analgesia. |