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.

Phase 3

Not yet recruiting

Conditions: Essential (primary) hypertension, (2) ICD-10 Condition: G958||Other specified diseases of spinalcord,

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.

Recruitment & Eligibility

Inclusion Criteria

Patients with ASA physical status 1 and 2 undergoing multilevel spine surgeries with or without instrumentation.

Exclusion Criteria

1.Subjects with pshychiatric illness, known allergy and contraindication to ketamine and lignocaine.
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.

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.

Locations (1): Department of Anesthesiology
🇮🇳
Bangalore, KARNATAKA, India
Department of Anesthesiology
🇮🇳Bangalore, KARNATAKA, India
Dr Poorva D Sarsu
Principal investigator
9538222649
poorva.bhargav5@gmail.com