Clinical Trials

Study 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

Primary Objective |

The primary objective of this study is to compare postsurgical pain control through 72 hours and opioid consumption through 90 days in patients receiving a multimodal regimen with local infiltration analgesia with EXPAREL® (bupivacaine liposome injectable suspension) and bupivacaine HCl (EXPAREL group) with those receiving standard of care (SOC) (control group) in adult subjects undergoing posterior lumbar spine surgeries.

Study Summary

Study Status: Startup

NCT Number: NCT03927911

Study Nickname: FUSION

Enrollment goal

goal

225

Intervention(s)

intervention

EXPAREL, SOC

Phase

phase

4

Condition

condition

Postsurgical pain management

Target Number of Sites: 15

Key Participation Criteria

Gender

gender

Both

Age

18-75years

Time Commitment

time

30 days

Procedures included

procedure

Posterior lumbar spine surgery

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for participation:

  • 18 to 75 years of age 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 (ie, not emergency)
    • Lumbosacral (ie, L1-S1)
    • Posterior approach with posterior instrumentation
  • Cohort 1 – Open cohort only: (Open or mini-open surgical technique with):
    • 1-level (ie, spanning 2 vertebrae) or 2-level (ie, spanning 3 contiguous vertebrae)
    • Primary fusion or revision fusion
    • Open or mini-open surgical technique
  • Cohort 2 – Tubular or percutaneous cohort only:
    • 1-level (ie, spanning 2 vertebrae) or 2-level (ie, 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

Exclusion Criteria:

Subjects who meet any of the following exclusion criteria will not be eligible for participation in this study:

  • Serious spinal pathology determined by Investigator that might meaningfully affect postsurgical outcomes, including any of the following:
    • Suspected cauda equina syndrome (eg, 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 the EXPAREL group
  • Anterior surgical approaches, including any of the following:
    • Anterior lumbar interbody fusion
    • Oblique lumbar interbody fusion
    • Anterior-posterior or 360º fusion
  • Lateral surgical approaches, including any of the following:
    • Extreme lateral interbody fusion
    • Direct lateral interbody fusion
  • High-dose presurgical opioid use
    • 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 nonsteroidal anti-inflammatory drug (NSAIDs)
    • 2 or more gabapentinoids
    • 2 or more rescue opioids (eg, oxycodone, morphine, hydromorphone)
    • 2 or more medications for postoperative nausea, vomiting, or pruritus (eg, dexamethasone, ondansetron)
  • History of severely impaired renal (eg, serum creatinine clearance ≤30) or hepatic function (eg, serum aspartate transaminase level [AST] >3 times the upper limit of normal [ULN] or serum alanine transaminase [ALT] level >3 x ULN
  • Severe chronic pain that requires analgesic treatment, and in the opinion of the principal Investigator, is likely to meaningfully affect postsurgical outcomes
  • Subjects that have an implanted spinal cord stimulator or intrathecal drug pump
  • Any neurologic or psychiatric disorder that might affect postsurgical pain or interfere with study assessments per Investigator discretion
  • Malignancy in the last 2 years
  • History of misuse, abuse, or dependence on opioid analgesics, other prescription drugs, illicit drugs, or alcohol as defined in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (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
  • Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration
  • Body Mass Index >44 kg/m2 at screening
  • Subjects receiving Worker’s Compensation for disability or who are involved in other litigation related to the spine
  • Planned concurrent surgical procedure
  • Previous participation in an EXPAREL study
  • 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.
    In addition, the subject might be excluded from the study prior to study drug infiltration if one of the following criteria during the surgical procedure is met:
    • Unable to place planned surgical instrumentation
    • Poor fixation at the time of surgical instrumentation

In addition, the subject must be considered an early termination if one of the following criteria after the surgical procedure is met:

  • An incision size >20 cm
  • Autograft taken from a harvest site other than surgical site (ie, iliac crest autograft)
  • Intraoperative complications likely to meaningfully affect postsurgical outcomes, including any of the following:
    • Clinically significant and prolonged (ie, >24 hours) neurologic deficit (eg, foot drop)
    • Dural tear or suspected dural tear requiring bed rest (exception: subject will be allowed if the dural tear is fixed as per SOC of the institution during surgery)
    • Extensive bleeding (ie, >1,000 mL blood loss)
    • Symptomatic epidural hematoma

Where to participate

Coordinates

NorthShore University HealthSystem  

2650 Ridge Avenue, Kellogg Center, 3rd Floor, Evanston, IL 60201

  • Principal Investigator

    Stadlan, Noam

The Spine Institute

2811 Wilshire Blvd. SUITE 850, Santa Monica, CA 90403

  • Principal Investigator

    Bae, Hyun

Children's Hospital of Wisconsin

9000 W. Wisconsin Ave , MS 792 , Milwaukee, WI 53226

  • Principal Investigator

    Roger Fons, MD

M3-Emerging Medical Research, LLC  

120 William Penn Plaza, Durham, NC 27704

  • Principal Investigator

    Musante, David

Marcus Neuroscience Institute

800 Meadows Road, Boca Raton, FL 33486

  • Principal Investigator

    Vrionis, Frank

Summit Spine Institute

9155 SW Barnes Road, Suite 210, Portland, OR 97225

  • Principal Investigator

    Sales, Jonathan

Bronson Methodist Hospital  

601 John St., Kalamazoo , MI 49007

  • Principal Investigator

    Fabi, Alain

The Orthopaedic Institute of Western Kentucky

4787 Alben Barkley Dr., Paducah, KY 42003

  • Principal Investigator

    Hill, Clint

Mayo Clinic

200 First St. SW, Rochester, MN 55905

  • Principal Investigator

    Bydon, Mohamad

Carolina NeuroSurgery & Spine Associates, P.A.

225 Baldwin Ave, Charlotte, NC 28204

  • Principal Investigator

    Coric, Domagoj

Southwest Scoliosis Institue

7777 Forest Lane, Plano, TX 75230

  • Principal Investigator

    Avramis, Ioannis

Univerity of Miami

1095 NW 14th Terrace, D-6, Miami, FL 33136

  • Principal Investigator

    Levi, Allan

The Ohio State University  

543 Taylor Ave, Columbus, OH 43203

  • Principal Investigator

    Khan, Safdar

Closest Location to Participate

NorthShore University HealthSystem  
2650 Ridge Avenue, Kellogg Center, 3rd Floor, Evanston, IL 60201
  • Principal Investigator

    Stadlan, Noam

Not Yet Recruiting

The Spine Institute
2811 Wilshire Blvd. SUITE 850, Santa Monica, CA 90403
  • Principal Investigator

    Bae, Hyun

Not Yet Recruiting

Children's Hospital of Wisconsin
9000 W. Wisconsin Ave , MS 792 , Milwaukee, WI 53226
  • Principal Investigator

    Roger Fons, MD

Recruiting

M3-Emerging Medical Research, LLC  
120 William Penn Plaza, Durham, NC 27704
  • Principal Investigator

    Musante, David

Not Yet Recruiting

Marcus Neuroscience Institute
800 Meadows Road, Boca Raton, FL 33486
  • Principal Investigator

    Vrionis, Frank

Not Yet Recruiting

Summit Spine Institute
9155 SW Barnes Road, Suite 210, Portland, OR 97225
  • Principal Investigator

    Sales, Jonathan

Not Yet Recruiting

Bronson Methodist Hospital  
601 John St., Kalamazoo , MI 49007
  • Principal Investigator

    Fabi, Alain

Not Yet Recruiting

The Orthopaedic Institute of Western Kentucky
4787 Alben Barkley Dr., Paducah, KY 42003
  • Principal Investigator

    Hill, Clint

Not Yet Recruiting

Mayo Clinic
200 First St. SW, Rochester, MN 55905
  • Principal Investigator

    Bydon, Mohamad

Not Yet Recruiting

Carolina NeuroSurgery & Spine Associates, P.A.
225 Baldwin Ave, Charlotte, NC 28204
  • Principal Investigator

    Coric, Domagoj

Not Yet Recruiting

Southwest Scoliosis Institue
7777 Forest Lane, Plano, TX 75230
  • Principal Investigator

    Avramis, Ioannis

Not Yet Recruiting

Univerity of Miami
1095 NW 14th Terrace, D-6, Miami, FL 33136
  • Principal Investigator

    Levi, Allan

Not Yet Recruiting

The Ohio State University  
543 Taylor Ave, Columbus, OH 43203
  • Principal Investigator

    Khan, Safdar

Not Yet Recruiting

If you have any questions for clinical trials, please contact to clinicaltrials@pacira.com.