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Clinical Trials/CTRI/2023/06/053512
CTRI/2023/06/053512Not yet recruitingNot Applicable

Effect of intravenous lignocaine on postoperative opioid consumption and recovery after posterior spine fusion surgeries - A randomized controlled trial.

Pondicherry Institute of Medical Sciences1 site in 1 country72 target enrollmentStarted: June 13, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
72
Locations
1
Primary Endpoint
To determine the effect of intraoperative intravenous lignocaine infusion on postoperative opioid consumption during first 24 hrs after posterior spine fusion surgeries under general anaesthesia in 72 participants.

Study Overview

Brief Summary

I am doing this study to evaluate the effect of a drug (intravenous lignocaine) on postoperative opioid consumption (pain) and recovery after  posterior spine fusion surgery. By being part of this study the patient may have decreased postoperative pain after the surgery and a better postoperative recovery.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Age 18-60 years of either sex.
  • •Patients belonging to American society of Anesthesiologist physical status1 and
  • •Patients undergoing posterior spine fusion surgeries under General anaesthesia.

Exclusion Criteria

  • •Patients with allergy to local anaesthetic.
  • •Patients undergoing spinal revision surgery .
  • •Patients with bradycardia (HR< 50 bpm) and any rhythm abnormalities
  • •Patients with seizure disorders.
  • •Patients with uncontrolled diabetes, hypertension, chronic kidney disease, active coronary artery disease and severe COPD and Asthma.

Outcomes

Primary Outcomes

To determine the effect of intraoperative intravenous lignocaine infusion on postoperative opioid consumption during first 24 hrs after posterior spine fusion surgeries under general anaesthesia in 72 participants.

Time Frame: 24 hrs

OUTCOME VARIABLES:

Time Frame: 24 hrs

VAS score in both the groups in first 24 hrs.

Time Frame: 24 hrs

Quality of recovery using QOR – 15 scale

Time Frame: 24 hrs

Postoperative opioid consumption

Time Frame: 24 hrs

Hemodynamic parameters (SBP, DBP &amp; MAP)

Time Frame: 24 hrs

Intraoperative opioid consumption

Time Frame: 24 hrs

Secondary Outcomes

  • 1.To compare the postoperative VAS score in first 24 hrs in both the groups .(2.To compare the hemodynamic parameters (SBP, DBP & MAP) during the intraoperative period in both the groups.)

Investigators

Sponsor Class
Research institution and hospital

Study Sites (1)

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