Phase 4 Study in Adult Subjects Undergoing Posterior Lumbar Spine Surgeries

NCT03927911 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 402-C-413
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 12

Brief Summary

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. 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. 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.

Conditions

Postoperative Pain Management

Outcome Measures

Primary Outcomes (1)

• Post-surgical Opioid Consumption in mg MED PO (0-72 Hours)

  Post-surgical opioid consumption in mg MED PO from 0 hours (end of surgery) to 72 hours postsurgery

  0-72 hours

Secondary Outcomes (2)

• Post-surgical Opioid Consumption in mg MED PO at 14 Days After Surgery

  0-14 days after surgery

• Time to First Opioid Rescue Through 72 Hours or Discharge.

  0-72 hours

Study Arms (3)

Open or mini-open surgical technique cohort

ACTIVE COMPARATOR

Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort

Drug: EXPAREL and Bupivacaine; Drug: Standard of Care

Tubular or Percutaneous cohort (Minimally Invasive Cohort)

ACTIVE COMPARATOR

Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort

Drug: EXPAREL and Bupivacaine; Drug: Standard of Care

Lumbar decompression without fusion (Outpatient Cohort)

ACTIVE COMPARATOR

Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort

Drug: EXPAREL and Bupivacaine; Drug: Standard of Care

Interventions

EXPAREL and Bupivacaine DRUG

Drug: EXPAREL and Bupivacaine HCl 0.5%

Lumbar decompression without fusion (Outpatient Cohort); Open or mini-open surgical technique cohort; Tubular or Percutaneous cohort (Minimally Invasive Cohort)

Standard of Care DRUG

Standard of Care

Lumbar decompression without fusion (Outpatient Cohort); Open or mini-open surgical technique cohort; Tubular or Percutaneous cohort (Minimally Invasive Cohort)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• level (i.e., spanning 2 vertebrae) or 2-level (i.e., spanning 3 contiguous vertebrae)
• Primary fusion or revision fusion

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)

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (12)

Yale School of Medicine

New Haven, Connecticut, 06511, United States

Location

Marcus Neuroscience Institute

Boca Raton, Florida, 33486, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

The Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, 42003, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Carolina NeuroSurgery & Spine Associates, P.A.

Charlotte, North Carolina, 28204, United States

Location

M3-Emerging Medical Research, LLC

Durham, North Carolina, 27704, United States

Location

The Ohio State University

Columbus, Ohio, 43203, United States

Location

Summit Spine Institute

Portland, Oregon, 97225, United States

Location

First Surgical Hospital

Bellaire, Texas, 77401, United States

Location

MeSH Terms

Interventions

Bupivacaine; Standard of Care

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Pacira Medical Information
• Organization: Pacira Pharmaceuticals

MedInfo@pacira.com

1-855-793-9727

Study Officials

• Gary Nevins, DC

  Pacira Pharmaceuticals, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: April 25, 2019
• Study Start: July 31, 2019
• Primary Completion: August 4, 2020
• Study Completion: August 4, 2020
• Last Updated: November 9, 2021
• Results First Posted: November 9, 2021

Record last verified: 2021-10

Locations

US (12)