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

S

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

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

Trial contacts and locations

1

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Central trial contact

Vladimir Solovyev, MD; Haim Berkenstadt, MD

Data sourced from clinicaltrials.gov

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