Phase 4 Study in Adult Subjects Undergoing Posterior Lumbar Spine Surgeries

Stopped early · Phase 4

Conditions studied: Postoperative Pain Management

In brief

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.

Key facts

Study ID

NCT03927911

Run by

Pacira Pharmaceuticals, Inc

People needed

65

Starts

2019-07-31

Expected to finish

2020-08-04

Last updated by the study team

2021-11-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18-75 years old at the time of screening.
• Primary surgical indication is related to spinal degenerative disease, including any of the following:
• Spinal stenosis
• Spondylolisthesis
• Radiculopathy/instability disc disorders
• Degenerative disc disease
• Medically cleared for elective spine surgery.
• Scheduled to undergo:
• Elective (i.e., not emergency)
• Lumbosacral (i.e., L1-S1)
• Posterior approach with posterior instrumentation
• Cohort 1 - Open only:
• Open or mini-open surgical technique with:
• 1-level (i.e., spanning 2 vertebrae) or 2-level (i.e., spanning 3 contiguous vertebrae)
• Primary fusion or revision fusion
• Open or mini-open surgical technique
• Cohort 2 - Tubular or percutaneous cohort only:
• 1-level (i.e., spanning 2 vertebrae) or 2-level (i.e., spanning 3 contiguous vertebrae)
• Primary fusion or revision fusion
• Tubular or percutaneous surgical technique
• Cohort 3 - Lumbar decompression without fusion outpatient cohort only:
• Radiculopathy
• Spinal stenosis
• Able to provide informed consent and adhere to all study assessments and visit schedule

You may not qualify if…

• Serious spinal pathology determined by Investigator that might meaningfully affect postsurgical outcomes, including any of the following:
• Suspected cauda equina syndrome (e.g., bowel/bladder involvement)
• Infection
• Tumor
• Fracture
• Systemic inflammatory spondyloarthropathy
• Contraindication to local anesthesia according to the clinical judgment of the Investigator and based on the EXPAREL label.
• Patients who most likely will require patient-controlled analgesia (PCA) pumps in EXPAREL group.
• Anterior surgical approaches, including any of the following:
• Anterior lumbar interbody fusion (ALIF)
• Oblique lumbar interbody fusion (OLIF)
• Anterior-posterior or 360º fusion
• Lateral surgical approaches, including any of the following:
• Extreme lateral interbody fusion (XLIF)
• Direct lateral interbody fusion (DLIF)
• High-dose presurgical opioid use:
• a) Mean daily intake greater than 100 mg mEq PO in the past 30 days
• Known allergy, hypersensitivity, or contraindication to any of the following study medications:
• Bupivacaine
• EXPAREL
• Tylenol (acetaminophen)
• Robaxin
• 2 or more NSAIDs
• 2 or more gabapentinoids
• 2 or more rescue opioids (e.g., oxycodone, morphine, hydromorphone)

Where it is running

• Yale School of Medicine — New Haven, Connecticut, United States
• Marcus Neuroscience Institute — Boca Raton, Florida, United States
• University of Miami — Miami, Florida, United States
• NorthShore University HealthSystem — Evanston, Illinois, United States
• The Orthopaedic Institute of Western Kentucky — Paducah, Kentucky, United States
• Bronson Methodist Hospital — Kalamazoo, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Carolina NeuroSurgery & Spine Associates, P.A. — Charlotte, North Carolina, United States
• M3-Emerging Medical Research, LLC — Durham, North Carolina, United States
• The Ohio State University — Columbus, Ohio, United States
• Summit Spine Institute — Portland, Oregon, United States
• First Surgical Hospital — Bellaire, Texas, United States

Full record on ClinicalTrials.gov

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