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Phase 4 Study in Adult Subjects Undergoing Posterior Lumbar Spine Surgeries (FUSION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927911
Recruitment Status : Active, not recruiting
First Posted : April 25, 2019
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc

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. 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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Management Drug: EXPAREL and Bupivacaine Drug: Standard of Care Phase 4

Detailed Description:

This is a Phase 4, multicenter, prospective, active-controlled, real world, study in approximately 225 adult subjects undergoing posterior lumbar spine surgery under general anesthesia.

Subjects will be screened within 30 days prior to surgery; screening on the day of surgery will be allowed but is discouraged. If a subject can only be screened on the day of surgery, the informed consent process must still be started at least 24 hours prior to the conduct of any screening procedures that are not considered SOC at the institution and such procedures may not be performed until written informed consent is provided. All screening procedures that are not SOC must be performed and documented within the 30-day time window (inclusive of the day of surgery for those subjects who can only be screened on the day of surgery) as described here.

During the screening visit, subjects will be assessed for any past or present medical conditions that in the opinion of the investigator would preclude them from study participation. After the ICF is signed, the following information will be recorded and procedures done: medical history, surgical history, medication history, the subject's opioid use history will be recorded to calculate mean daily mg oral morphine equivalent dosing (MED PO) in the last 30 days, demographic and background information, height, weight and body mass index (BMI), a urine pregnancy test for women of childbearing potential, and the subject's current adverse experiences (AEs), if any.

Subjects will be asked questions and/or be asked to fill forms as part of the following assessments: Brief Pain Inventory - short form (BPI-sf), 5-item Opioid Compliance Checklist (OCC), Hospital Anxiety and Depression Scale (HADS), Survey of Pain Attitudes (SOPA), Numeric Rating Scale (NRS) ti assess pain and Opioid Related Symptom Distress Scale (ORSDS).

Based on the planned surgical procedure, subjects will be placed in one of three cohorts:

  • Cohort 1 - Open lumbar spinal fusion technique; ("open" cohort)
  • Cohort 2 - Minimally invasive tubular and/or percutaneous pedicle screw insertion for lumbar decompression with or without fusion;("tubular/percutaneous without midline incision" cohort)
  • Cohort 3 - Lumbar decompression surgery (LDS) without fusion (discectomy or laminectomy outpatient cohort)

Number of Subjects (Planned):

The initial sample size in each study cohort (i.e., cohort 1, cohort 2 and cohort 3) is estimated at 75 subjects (50 subjects with EXPAREL and 25 subjects with Control group), for a total of 225 subjects in all three cohorts. Within each assigned cohort, subjects will be allocated in a 2:1 ratio to the EXPAREL (50 subjects) and Control group (25 subjects).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective, Active Controlled, Real World, Phase 4 Study of EXPAREL in Multimodal Regimens Compared With Standard of Care for Postsurgical Pain Management in Subjects Undergoing Lumbar Posterior Spine Surgeries
Actual Study Start Date : July 31, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Open or mini-open surgical technique cohort
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: EXPAREL and Bupivacaine HCl 0.5%

Drug: Standard of Care
Standard of Care

Active Comparator: Tubular or Percutaneous cohort (Minimally Invasive Cohort)
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: EXPAREL and Bupivacaine HCl 0.5%

Drug: Standard of Care
Standard of Care

Active Comparator: Lumbar decompression without fusion (Outpatient Cohort)
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: EXPAREL and Bupivacaine HCl 0.5%

Drug: Standard of Care
Standard of Care




Primary Outcome Measures :
  1. Post-surgical opioid consumption in mg MED PO (0-72 hours) [ Time Frame: An average of 1 year ]
    Post-surgical opioid consumption in mg MED PO from 0 hours (end of surgery) to 72 hours postsurgery


Secondary Outcome Measures :
  1. Post-surgical opioid consumption in mg MED PO at 14 days after surgery [ Time Frame: An average of 1 year ]
  2. Time to first opioid rescue through 72 hours or discharge. [ Time Frame: An average of 1 year ]
  3. Opioid Related Symptom Distress Scale (OR-SDS) [ Time Frame: An average of 1 year ]
    Opioid related adverse events will be assessed by using the Opioid Related Symptoms Distress Scale (OR-SDS) at 24, 48, and 72 hours postsurgery, at discharge, and at 14 days.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18-75 years old at the time of screening.
  2. Primary surgical indication is related to spinal degenerative disease, including any of the following:

    1. Spinal stenosis
    2. Spondylolisthesis
    3. Radiculopathy/instability disc disorders
    4. Degenerative disc disease
  3. Medically cleared for elective spine surgery.
  4. Scheduled to undergo:

    1. Elective (i.e., not emergency)
    2. Lumbosacral (i.e., L1-S1)
    3. Posterior approach with posterior instrumentation
  5. Cohort 1 - Open cohort only: (Open or mini-open surgical technique with):

    1. 1-level (i.e., spanning 2 vertebrae) or 2-level (i.e., spanning 3 contiguous vertebrae)
    2. Primary fusion or revision fusion
    3. Open or mini-open surgical technique
  6. Cohort 2 - Tubular or percutaneous cohort only:

    1. 1-level (i.e., spanning 2 vertebrae) or 2-level (i.e., spanning 3 contiguous vertebrae)
    2. Primary fusion or revision fusion
    3. Tubular or percutaneous surgical technique
  7. Cohort 3 - Lumbar decompression without fusion outpatient cohort only:

    1. Radiculopathy
    2. Spinal stenosis
  8. Able to provide informed consent and adhere to all study assessments and visit schedule

Exclusion Criteria:

  1. Serious spinal pathology determined by Investigator that might meaningfully affect postsurgical outcomes, including any of the following:

    1. Suspected cauda equina syndrome (e.g., bowel/bladder involvement)
    2. Infection
    3. Tumor
    4. Fracture
    5. Systemic inflammatory spondyloarthropathy
  2. Contraindication to local anesthesia according to the clinical judgment of the Investigator and based on the EXPAREL label.
  3. Patients who most likely will require PCA pumps in EXPAREL group.
  4. Anterior surgical approaches, including any of the following:

    1. Anterior lumbar interbody fusion (ALIF)
    2. Oblique lumbar interbody fusion (OLIF)
    3. Anterior-posterior or 360º fusion
  5. Lateral surgical approaches, including any of the following:

    1. Extreme lateral interbody fusion (XLIF)
    2. Direct lateral interbody fusion (DLIF)
  6. High-dose presurgical opioid use:

    a) Mean daily intake greater than 100 mg mEq PO in the past 30 days

  7. Known allergy, hypersensitivity, or contraindication to any of the following study medications:

    1. Bupivacaine
    2. EXPAREL
    3. Tylenol (acetaminophen)
    4. Robaxin
    5. 2 or more NSAIDs
    6. 2 or more gabapentinoids
    7. 2 or more rescue opioids (e.g., oxycodone, morphine, hydromorphone)
    8. 2 or more medications for postoperative nausea, vomiting, or pruritus (e.g., dexamethasone, ondansetron)
  8. History of severely impaired renal or hepatic function.
  9. Severe chronic pain that requires analgesic treatment, and in the opinion of the principal Investigator, is likely to meaningfully impact postsurgical outcomes.
  10. Subjects that have implanted spinal cord stimulator or intrathecal drug pump.
  11. Any neurologic or psychiatric disorder that might impact postsurgical pain or interfere with study assessments per Investigator discretion.
  12. Malignancy in the last 2 years.
  13. History of misuse, abuse, or dependence on opioid analgesics, other prescription drugs, illicit drugs, or alcohol as defined in DSM-5. Dependence or chronic opioid use will be defined as use of more than 30 morphine equivalents per day during the prior 90 days.
  14. Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
  15. Body Mass Index < 17 kg/m2 or >44 kg/m2 at screening
  16. Subjects receiving Worker's Compensation for disability or who are involved in other litigation related to the spine.
  17. Planned concurrent surgical procedure.
  18. Previous participation in an EXPAREL study.
  19. Administration of any investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927911


Locations
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United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06511
United States, Florida
Marcus Neuroscience Institute
Boca Raton, Florida, United States, 33486
University of Miami
Miami, Florida, United States, 33136
United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
United States, Kentucky
The Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, United States, 42003
United States, Michigan
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, North Carolina
Carolina NeuroSurgery & Spine Associates, P.A.
Charlotte, North Carolina, United States, 28204
M3-Emerging Medical Research, LLC
Durham, North Carolina, United States, 27704
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43203
United States, Oregon
Summit Spine Institute
Portland, Oregon, United States, 97225
United States, Texas
First Surgical Hospital
Bellaire, Texas, United States, 77401
Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Investigators
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Study Director: Nayana Nagaraj, MD, PhD, MPH Pacira Pharmaceuticals, Inc
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Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT03927911    
Other Study ID Numbers: 402-C-413
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents