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Liposomal Bupivacaine in One-level Instrumented Posterior Spinal Fusion

NCT03745040 · Status: SUSPENDED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-12-11

No results posted yet for this study

Summary

This study will describe postoperative pain management for spine surgery patients receiving liposomal bupivacaine (Exparel®) compared to patients not receiving the drug.

Conditions

  • Lumbar Spinal Stenosis
  • Lumbar Disc Herniation
  • Lumbar Disc Disease
  • Lumbar Spondylolisthesis

Interventions

DRUG

Liposomal bupivacaine

20ml bupivacaine liposome injectable suspension 1.3% (266mg) + 50ml 0.25% Bupivacaine (150mg) + 70ml preservative-free 0.9% neutral saline

Sponsors & Collaborators

  • Twin Cities Spine Center

    collaborator OTHER

  • Allina Health System

    lead OTHER

Principal Investigators

  • Christopher Alcala-Marquez, MD · Allina Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-26
Primary Completion
2021-09-20
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03745040 on ClinicalTrials.gov