Spinal Diseases
Conditions
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.
Interventions
DRUGLidocaine
Lidocaine drip during surgery
Sponsors
Sheba Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* spine surgery with general anesthesia
Exclusion criteria
* lidocaine allergy * hepatic disease * dementia or cognitive decline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | 24 hours postop | Quality of recovery after surgery will be assessed using Q0R15 questionnaire and analgesic requirement will be monitored using PCA |
Countries
Israel
Contacts
Primary ContactHaim Berkenstadt, MD
Backup ContactVladimir Solovyev, MD
Outcome results
None listed