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NCT03624985 · ClinicalTrials.gov registry record · Phase 4
The Effect of Perioperative Intravenous Lidocaine Infusion on Opioid Consumption After Lumbar Spine Surgery
A Phase 4 study, sponsored by University of Vermont Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 61
- Enrollment target
NCT03624985: Clinical Trial Phase 4 study, sponsored by University of Vermont Medical Center.
NCT03624985 is a Phase 4 study that was terminated before completion, run by University of Vermont Medical Center. The registered enrollment target is 61 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03624985, a Phase 4 study, was terminated before completion, sponsored by University of Vermont Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 61 participants
- Enrollment target
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.
Primary Outcome
Subjects will receive a patient-controlled analgesia pump for the first 24 hours after surgery. Total morphine equivalent will be calculated according to the Centers for Disease Control and Prevention conversion factor for calculating morphine milligram equivalents.
Interventions
- DRUG Placebo Infusion
- DRUG Intravenous Lidocaine Infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2018-06-04 |
| Est. Completion | 2019-10-14 |
| Phase | Phase 4 |
Why NCT03624985 stopped before completion
NCT03624985 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Infusion is the first listed.
NCT03624985 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03624985 about?
NCT03624985 is a clinical study titled "The Effect of Perioperative Intravenous Lidocaine Infusion on Opioid Consumption After Lumbar Spine Surgery". 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...
What is the current status of trial NCT03624985?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 61 participants. The study started on 2018-06-04. Estimated completion is 2019-10-14.
What interventions are being tested in trial NCT03624985?
The interventions under investigation include: Placebo Infusion (DRUG), Intravenous Lidocaine Infusion (DRUG).
Who is sponsoring clinical trial NCT03624985?
This trial is sponsored by University of Vermont Medical Center, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03624985's enrollment target sits among peer trials
61 1119th of 2000 higher than 876 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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