Phase 4 Study in Adult Subjects Undergoing Posterior Lumbar Spine Surgeries
Public ClinicalTrials.gov record NCT03927911. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Prospective, Active Controlled, Real World, Phase 4 Study of EXPAREL in Multimodal Regimens Compared With Standard of Care for Postsurgical Pain Management in Subjects Undergoing Lumbar Posterior Spine Surgeries (FUSION)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: The primary objective of this study is to compare postsurgical opioid consumption through 72 hours postsurgery in patients receiving local infiltration analgesia (LIA) with EXPAREL and bupivacaine HCl (EXPAREL group) with that of patients receiving standard of care (SOC) (control group) in adult subjects undergoing posterior lumbar spine surgeries where both groups are receiving a multimodal pain regimen. Secondary Objectives: The secondary objectives of this study are to: 1. Compare safety and effectiveness outcomes following LIA with EXPAREL and bupivacaine hydrochloride (HCl) versus SOC in adult subjects undergoing posterior lumbar spine surgeries through 72 hours, including time to first opioid and opioid-related adverse events (ORAEs). 2. Compare health outcomes following LIA with EXPAREL and bupivacaine hydrochloride (HCl) versus SOC in adult subjects undergoing posterior lumbar spine surgeries, including discharge readiness, hospital (or other facility) length of stay (LOS), discharge disposition, hospital readmissions, and health service utilization.
Study identification
- NCT ID
- NCT03927911
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 65 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2019 (Actual)
- Primary completion
- Aug 4, 2020 (Actual)
- Completion
- Aug 4, 2020 (Actual)
- Last update posted
- Nov 9, 2021
2019 – 2020
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Yale School of Medicine | New Haven | Connecticut | 06511 | — |
| Marcus Neuroscience Institute | Boca Raton | Florida | 33486 | — |
| University of Miami | Miami | Florida | 33136 | — |
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | — |
| The Orthopaedic Institute of Western Kentucky | Paducah | Kentucky | 42003 | — |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Carolina NeuroSurgery & Spine Associates, P.A. | Charlotte | North Carolina | 28204 | — |
| M3-Emerging Medical Research, LLC | Durham | North Carolina | 27704 | — |
| The Ohio State University | Columbus | Ohio | 43203 | — |
| Summit Spine Institute | Portland | Oregon | 97225 | — |
| First Surgical Hospital | Bellaire | Texas | 77401 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03927911, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 9, 2021 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03927911 live on ClinicalTrials.gov.