CTRI

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CTRI Number

CTRI/2021/07/035237 [Registered on: 29/07/2021] Trial Registered Prospectively

Last Modified On:

27/07/2021

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Comparison oftwo drugs that help in relief of post operative pain in patients undergoing spine surgeries under General Anesthesia, where ketamine and lignocaine injection is used to reduce pain.

Scientific Title of Study

Comparison of the effect of intraoperative ketamine and lignocaine infusion on early post operative pain relief in patients undergoing spine surgeries under general anesthesia.

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Poorva D Sarsu
Designation	Anesthesia PG Resident
Affiliation	M S Ramiah Medical ollege
Address	Postgraduate, Department of Anesthesiology M S Ramaiah Medical College New BEL road M R Ramaiah Nagar MSRIT Post Bangalore Bangalore KARNATAKA 560054 India
Phone	9538222649
Fax
Email	poorva.bhargav5@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Yatish B
Designation	Associate Professor, Department of Anesthesia
Affiliation	M S Ramaiah Medical College
Address	Department of Anesthesiology M S Ramaiah Medical College New BEL road M R Ramaiah Nagar MSRIT Post Bangalore Bangalore KARNATAKA 560054 India
Phone	9886197658
Fax
Email	yatishseeni@yahoo.co.in

Details of Contact Person
Public Query

Name	Dr Yatish B
Designation	Associate Professor, Department of Anesthesia
Affiliation	M S Ramaiah Medical College
Address	Department of Anesthesiology M S Ramaiah Medical College New BEL road M R Ramaiah Nagar MSRIT Post Bangalore Bangalore KARNATAKA 560054 India
Phone	9886197658
Fax
Email	yatishseeni@yahoo.co.in

Source of Monetary or Material Support

M S Ramaiah Medical college

Primary Sponsor

Name	M S Ramiah Medical College
Address	M S Ramaiah Medical College New BEL Road MS Ramaih Nagar MSRIT Post Bangalore Karnataka 560054 INDIA
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
Dr Poorva D Sarsu	Department of Anesthesiology	Department of Anesthesiology OT Complex M S Ramaiah Mediacl College and Hospital New BEL Road M S Ramaiah Nagar MSRIT Post Bangalore Karnataka Bangalore KARNATAKA	9538222649 poorva.bhargav5@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
M S Ramaiah Medical College	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	, , (1) ICD-10 Condition: I10\|\|Essential (primary) hypertension, (2) ICD-10 Condition: G958\|\|Other specified diseases of spinalcord,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Iv ketamine	Group K will receive IV ketamine bolus of 0.5mg/kg over 3 minutes followed by infusion of 0.2mg/kg/hr intraoperatively.
Comparator Agent	Iv Lignocaine	Immediately after induction group L will receive IV lignocaine bolus of 1.5mg/kg over 3 minutes followed by continuous infusion of 1mg/kg/hr intraoperatively.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	Patients with ASA physical status 1 and 2 undergoing multilevel spine surgeries with or without instrumentation.

ExclusionCriteria

Details

1.Subjects with pshychiatric illness, known allergy and contraindication to ketamine and lignocaine.
2. history of drug abuse and dependence to opioids and alcohol.
3.BMI >30kg/m2
4.Patients with chronic pain disorder.
5.Liver Cirrhosis (SGOT/SGPT >2 times normal) and chronic renal failure (s.creatinine >2mg/dl)
6.Severe cardio vascular disease
7.Epilepsy and other neurological disorder.

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
To measure and compare visual analogue score (VAS) in the post anesthesia care unit (PACU) at rest and with movement in both the groups.	Immediately on arrival to PACU and at every 15mins interval for first hour i.e 15mins, 30mins, 45mins and 60mins.

Secondary Outcome

Outcome	TimePoints
To evaluate and compare analgesic requirement, haemodynamic effects like bradycardia, tachycardia, hypertension and occurance of adverse effects if any due to lignocaine and ketamine use.	Baseline, post induction, post intubation, post positioning for surgery, 15mins, 30mins, 45mins, 60mins, 75mins, 90mins, post extubation, 5mins post extubation.

Target Sample Size

Total Sample Size="44"
Sample Size from India="44"
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 3

Date of First Enrollment (India)

02/08/2021

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="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

Individual Participant Data (IPD) Sharing Statement

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

Response - YES

What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiﬁcation.

What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.

For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.

By what mechanism will data be made available?
Response (Others) - BY EMAIL

For how long will this data be available start date provided 01-06-2021 and end date provided 01-11-2022?
Response - Beginning 3 months and ending 5 years following article publication.

Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NO

Brief Summary

Extensive spine surgeries are mostly elective in nature with significant post operative pain. Opioids have been the mainstay of post operative pain management. However opioids have their own adverse effects and these patient population are at a high risk of developing opioid induced hyperalgesia and tolerance.

Standardized care pathways like Enhanced Recovery After Surgery (ERAS) programs have been shown to improve perioperative outcomes. Multimodal anagesic regimens form the essential components of ERAS programs. A diverse array of pharmacological options exist for treating post operative pain.

Systemic lignocaine is anti inflammatory, analgesic and hyperalgesic, these effects are mediated by inhibition of N-Mrthyl D-Aspartate ?(NMDA) and leucocyte priming. In addition lignocaine stimulates secretion of anti inflammatory cytokines IL-1receptor antagonist.Ketamine is a non competitive NMDA antagonist in central and peripheral nervous system. Ketamine attenuates central sensitization and hyperalgesia, thereby reducing post operative opioid tolerance.

Both lignocaine and ketamine have been shown to be safe and effective adjuvants to decrease opioid consumption and decrease early pain.

The aim of the study is to evaluate and compare the effects of perioperative intravenous lignocaine and ketamine on post operative analgesic requirement, VAS scores and any adverse effects after elective spine surgeries.