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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Local infiltration of EXPAREL and Bupivacaine

Group Type ACTIVE_COMPARATOR

Exparel

Intervention Type DRUG

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

Bupivacaine

Intervention Type DRUG

30 mL bupivacaine 0.5% w/v solution

Local infiltration of Exparel

Group Type ACTIVE_COMPARATOR

Exparel

Intervention Type DRUG

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

Local infiltration of Bupivacaine

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

30 mL bupivacaine 0.5% w/v solution

Interventions

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Exparel

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

Intervention Type DRUG

Bupivacaine

30 mL bupivacaine 0.5% w/v solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age 18 or older;
2. Primary indication is low back pain, lumbosacral radiculopathy, lumbar disc degeneration, lumbar disc herniation, stenosis, spondylolisthesis, spondylolysis, or deformity requiring surgical intervention;
3. Scheduled to undergo primary, 1 or 2 level, posterior lumbar laminectomy with or without fusion, discectomy with fusion, or fusion at Virtua Memorial Hospital;
4. Willing to provide informed consent, participate in study, and comply with study protocol.

Exclusion Criteria

1. Hypersensitivity or allergy to local anesthetics;
2. Pregnant or contemplating pregnancy prior to surgery;
3. Previous surgery in lumbar spine (i.e. other than microdiscectomy);
4. Prior treatment for alcohol, recreational drug, or opioid abuse;
5. Serious spinal conditions (e.g. spinal cord compression, cauda equina syndrome, spinal infection, spinal tumor, spinal fracture, inflammatory or systemic spinal arthritis);
6. Surgery involving more than 2 vertebral levels;
7. Worker's compensation or personal injury related to lumbar spine (treatment outcomes may be affected by patient's personal interests \[21\]; could also run into potential issues with reimbursement).
8. Lactating women
9. Patients with end stage liver disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes