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

Spinal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02762656
• Other study ID #: SHEBA-16-2972-VS-CTIL
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 3, 2016
• Last updated: May 3, 2016
• Start date: June 2016
• Est. completion date: August 2017

Study information

• Verified date: May 2016
• Source: Sheba Medical Center
• Contact: Haim Berkenstadt, MD
• Phone: 03-5302754
• Email: Haim.Berkenstadt[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• spine surgery with general anesthesia

Exclusion Criteria:

• lidocaine allergy

• hepatic disease

• dementia or cognitive decline

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Diseases

Intervention

Drug:
• Lidocaine
Lidocaine drip during surgery

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	Quality of recovery after surgery will be assessed using Q0R15 questionnaire and analgesic requirement will be monitored using PCA	24 hours postop	No

External Links

•   Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery.
•   Intraoperative systemic infusion of lidocaine reduces postoperative pain after lumbar surgery: a double-blinded, randomized, placebo-controlled clinical trial.
•   Intravenous lidocaine for effective pain relief after a laparoscopic colectomy: a prospective, randomized, double-blind, placebo-controlled study.