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Phase 4, Controlled Study in Adult Subjects Undergoing Primary, 1-2 Level, Open Lumbar Spinal Fusion Surgery

NCT03015961 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-10-13

Study results available
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Summary

Primary Objective: The primary objective of this study is to compare postsurgical pain control following local infiltration analgesia (LIA) with EXPAREL admixed with bupivacaine HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar posterior spinal fusion surgery.

Secondary Objectives: The secondary objectives of this study are to compare additional efficacy, safety, and health economic outcomes following LIA with EXPAREL admixed with bupivacaine HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar posterior spinal fusion surgery.

Conditions

  • Postoperative Pain Management

Interventions

DRUG

EXPAREL and bupivacaine HCl

Drug: EXPAREL EXPAREL and bupivacaine HCl Other Name: bupivacaine liposome injectable suspension Drug: Bupivacaine Single dose of bupivacaine HCl 0.5% Other Name: bupivacaine HCl

DRUG

Bupivacaine HCl

Drug: Bupivacaine Single dose of bupivacaine HCl 0.5% Other Name: bupivacaine HCl

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-21
Primary Completion
2017-10-30
Completion
2017-10-30
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 NCT03015961 on ClinicalTrials.gov