MedTrace Logo

The Effect of Perioperative Intravenous Lidocaine Infusion on Opioid Consumption After Lumbar Spine Surgery

NCT03624985 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2023-01-31

No results posted yet for this study

Summary

The purpose of this study is to determine whether an infusion of lidocaine during surgery can reduce the need for postoperative opioid pain medication use in patients undergoing lumbar spine surgery.

Participants will be recruited by spine surgeons from their pool of patients who are presenting for surgery at University of Vermont Medical Center. If they agree to participate, patients will be assigned at random to receive either an infusion of lidocaine during surgery, or an infusion of saline with 5% dextrose. Subjects will also be asked to complete a 15-item questionnaire that asks about health, quality of life, and level of pain, at three timepoints. Patients will also be asked to rate their level of pain at multiple timepoints after surgery, and we will collect the additionally data from patients' medical records.

Conditions

  • Pain, Postoperative
  • Opioid Use

Interventions

DRUG

Intravenous Lidocaine Infusion

Patients will be randomly assigned to receive 1 mg/kg lidocaine bolus and intraoperative infusion of 2 mg/min.

DRUG

Placebo Infusion

Patients will be randomly assigned to receive a 1mg/kg bolus of water with 5% dextrose and an intraoperative infusion of 2mg/min. of water with 5% dextrose

Sponsors & Collaborators

  • University of Vermont Medical Center

    lead OTHER

Principal Investigators

  • Timothy Dominick, MD · Anesthesiologist

  • David Lunardini, MD · Orthopedic Surgeon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-04
Primary Completion
2019-10-14
Completion
2019-10-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03624985 on ClinicalTrials.gov