| CTRI Number |
CTRI/2026/04/107570 [Registered on: 06/04/2026] Trial Registered Prospectively |
| Last Modified On: |
03/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Want to study effect of intravenous lignocaine in post operative pain in spine surgery |
|
Scientific Title of Study
|
A Randomized Controlled Study To Evaluate The Effect Of Intraoperative Intravenous Lignocaine Infusion On Early Postoperative Pain After Elective Lumbar Spine Surgeries At SMS Medical College And Hospital 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 |
Neelu Sharma |
| Designation |
Professor |
| Affiliation |
Sms Medical College And Hospital |
| Address |
Neurosurgery OT Department Of Anaesthesia Sms Hospital
Jaipur
RAJASTHAN
302004
India |
| Phone |
9782480455 |
| Fax |
|
| Email |
drneelu13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neelu Sharma |
| Designation |
Professor |
| Affiliation |
Sms Medical College And Hospital |
| Address |
Neurosurgery OT Department Of Anaesthesia Sms Hospital
Jaipur
RAJASTHAN
302004
India |
| Phone |
9782480455 |
| Fax |
|
| Email |
drneelu13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rashi Agarwal |
| Designation |
Resident Doctor |
| Affiliation |
SMS Medical college and hospital |
| Address |
Jawahar lal Nehru Marg SMS medical college and hospital Jaipur Rajasthan
Department of Anaesthesiology SMS medical college and hospital Jaipur Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9588291413 |
| Fax |
|
| Email |
lakshay199888@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology SMS medical college and hospital Jaipur Rajasthan 302004 |
|
|
Primary Sponsor
|
| Name |
Sawai Mansingh Medical College and Hospital |
| Address |
Department Of Anaesthesiology 2nd Floot OT Dhanwantri building 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 RASHI AGARWAL |
SMS Medical college and hospital |
Department of Anaesthesiology operative theatre 2 SMS medical college and hospital Jaipur Rajasthan 302004
Jaipur
RAJASTHAN |
9588291413
lakshay199888@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 Hospital 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 |
60 mg intravenous before surgery and 90 mg intravenous infusion just before end of surgery, effect seen up to 24 hour post surgery |
| Comparator Agent |
Saline |
Used as blinding for lignocaine preparation(placebo) |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient undergoing elective Lumbar spine surgery
with informed written consent
Patients of either gender with age group ranging from 25 to 60 years.
ASA grade I and II
|
|
| ExclusionCriteria |
| Details |
Patients with a known history of hepatic or renal dysfunction, atrio-ventricular block.
History of hypersensitivity to study medication.
Patients having history of previous back surgery
Patient with history of drug abuse
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean time to demand first rescue analgesia
Mean rescue analgesic consumption
Mean NRS value
Proportion of patients experiencing side effects
Mean haemodynamic parameters( HR, SBP, DBP, MBP) |
15 Min,30 min,45 min,60 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/04/2026 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
In spine surgeries, post operative pain is very challenging.So we are using intravenous Lignocaine to see effect on pain post operatively after spine surgeries. |