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NCT03893318 · ClinicalTrials.gov registry record · Phase 4
IV Lidocaine in Pediatric AIS
A Phase 4 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
NCT03893318 is a Phase 4 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 15 participants.
The verdict
NCT03893318, a Phase 4 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
Study Summary
This study addresses the focus areas of Post-Operative Pain Management. We propose a randomized, triple-blind, placebo-controlled trial to investigate the efficacy of a systemic infusion of intravenous lidocaine as a non-opioid method of post-operative pain management following postoperative spinal fusion for adolescent idiopathic scoliosis (AIS). The outcomes assessed will be (1) the effect of intravenous lidocaine on post-operative opioid consumption, both in-hospital and at three-month follow-up, (2) the effect of intravenous lidocaine on the immunophenotype expressed following surgery, and (3) the effect of intravenous lidocaine on recovery from surgery as assessed by the Patient Reported Outcomes Measurement Information System-Computer Adaptive Tests for Pain Interference (PI) and Mobility (M) (PROMIS-CAT). Thus, we propose a study of a non-opioid method of pain control to minimize opioid consumption in-hospital and at three-months postoperatively, with primary outcomes measures that include morphine-equivalent opioid consumption and PROMIS-Mobility to assess recovery. In addition, we will test the ability of systemic lidocaine to attenuate the systemic inflammatory response to major spine surgery. The immunologic response to surgery has been associated with rehabilitation and recovery following total hip arthroplasty and this study will provide data to support further work.
Interventions
- DRUG Placebos
- DRUG IV lidocaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-07-30 |
| Est. Completion | 2024-12-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03893318
The ClinicalTrials.gov registry entry for NCT03893318 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT03893318 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03893318 about?
NCT03893318 is a clinical study titled "IV Lidocaine in Pediatric AIS". This study addresses the focus areas of Post-Operative Pain Management. We propose a randomized, triple-blind, placebo-controlled trial to investigate the efficacy of a systemic infusion of intravenous lidocaine as a non-opioid method of post-operative pain management following postoperative spinal ...
What is the current status of trial NCT03893318?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2019-07-30. Estimated completion is 2024-12-31.
What interventions are being tested in trial NCT03893318?
The interventions under investigation include: Placebos (DRUG), IV lidocaine (DRUG).
Who is sponsoring clinical trial NCT03893318?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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