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Clinical Trials/NCT02762656
NCT02762656
Unknown
Phase 4

The Effect of Perioperative Lidocaine Intravenous Infusion on Postoperative Recovery After Spine Surgery.

Sheba Medical Center1 site in 1 country60 target enrollmentJune 2016
ConditionsSpinal Diseases
InterventionsLidocaine

Overview

Phase
Phase 4
Intervention
Lidocaine
Conditions
Spinal Diseases
Sponsor
Sheba Medical Center
Enrollment
60
Locations
1
Primary Endpoint
Postoperative pain
Last Updated
9 years ago

Overview

Brief Summary

The purpose of this study is to evaluate the effectiveness of perioperative Lidocaine intravenous infusion in reducing postoperative pain for spine surgery patients.

Detailed Description

Study design: this study used a prospective, randomized, double-blinded, and placebo-controlled clinical trial. Sixty patients scheduled for a spine surgery will be randomly assigned to two groups. Lidocaine group will receive an intravenous bolus injection of lidocaine 1.5 mg/kg before intubation, followed by 2 mg/kg/h continuous infusion during the operation. Placebo group will receive the same dosage of saline at the same time. Analgesic requirement will be monitored using patient-controlled Analgesia (PCA protocol: demand dose is 2 mg of morphine, lockout 5 min, maximum dose 15 mg per hour). Forty-eight hours after surgery, we will check the morphine consumption in two groups. Quality of recovery after surgery will be assessed using Q0R15 questionnaire.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
August 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • spine surgery with general anesthesia

Exclusion Criteria

  • lidocaine allergy
  • hepatic disease
  • dementia or cognitive decline

Arms & Interventions

Lidocaine

Patients will receive Lidocaine drip during spine surgery

Intervention: Lidocaine

Placebo

Patients will receive placebo during spine surgery

Intervention: Lidocaine

Outcomes

Primary Outcomes

Postoperative pain

Time Frame: 24 hours postop

Quality of recovery after surgery will be assessed using Q0R15 questionnaire and analgesic requirement will be monitored using PCA

Study Sites (1)

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