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

Sheba Medical Center

Status and phase: Unknown; Phase 4

Conditions: Spinal Diseases

Treatments: Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02762656

SHEBA-16-2972-VS-CTIL

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• spine surgery with general anesthesia

Exclusion criteria

• lidocaine allergy
• hepatic disease
• dementia or cognitive decline

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Lidocaine

Active Comparator group

Description:

Patients will receive Lidocaine drip during spine surgery

Treatment:

Drug: Lidocaine

Placebo

Placebo Comparator group

Description:

Patients will receive placebo during spine surgery

Treatment:

Drug: Lidocaine