drugset / Trial / NCT03624985

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

NCT03624985 ↗

Phase 4 Terminated 61 enrolled University of Vermont Medical Center
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2018-06-04
Primary completion
2019-10-14
Completion
2019-10-14

Outcome

Outcome not reported

Stopped: “Subjects had a high dropout rate. Of 61 consented, 24 did not participate. Reasons: Surgical cancellations; changing procedure type after consent; and staffing issues. The dropout rate of 39% was considered a barrier to publication.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Lidocaine Other / unclassified 2 mg Intravenous