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A Prospective Study to Compare Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Pain Relief

NCT03514277 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2021-01-06

Study results available
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Summary

The purpose of this study is to collect information about how patients feel when doctors manage their pain after lumbar spine surgery using a combination of EXPAREL® and bupivacaine injected into the lumbar spine at the end of surgery, compared to the patients that doctors use only EXPAREL® or bupivacaine to manage their pain. This information will help doctors determine which approach works best for patients who will receive surgery in their lumbar spine in the future.

Conditions

  • Low Back Pain
  • Lumbosacral Radiculopathy
  • Lumbar Disc Degeneration
  • Lumbar Disc Herniation
  • Stenosis
  • Spondylolisthesis
  • Spondylolysis
  • Deformity of Spine

Interventions

DRUG

Exparel

1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL

DRUG

Bupivacaine

30 mL bupivacaine 0.5% w/v solution

Sponsors & Collaborators

  • Virtua Health, Inc.

    lead OTHER

Principal Investigators

  • Robert Greenleaf, MD · Princpal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-01
Primary Completion
2019-12-31
Completion
2019-12-31
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 NCT03514277 on ClinicalTrials.gov