A Study of the Effectiveness of EXPAREL for Pain Control in Adult Subjects Undergoing Open Lumbar Spinal Fusion Surgery

Overview

About this study

The purpose of this study is to compare postsurgical pain control following local infiltration analgesia and bupivacaine HCl with EXPAREL, versus without EXPAREL, in adult subjects undergoing open lumbar spinal fusion surgery. The study will also compare additional effectiveness, safety, and health economic outcomes.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Male or female
  • At least age 18 years at screening
  • Primary surgical indication is lumbar pain, radiculopathy, disc degeneration, disc herniation, foraminal stenosis, or 1-2 level spondylolisthesis or deformity.
  • Scheduled to undergo primary, 1-2 level, open spine fusion under general anesthesia
  • American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
  • Female subjects must be
    • Surgically sterile
    • At least 2 years postmenopausal
    • Have a monogamous partner who is surgically sterile
    • Practicing double-barrier contraception
    • Practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity)
    • Using an insertable, injectable, or transdermal, contraceptive approved by the FDA for greater than 2 months prior to screening
  • All women of childbearing potential (ie, premenopausal without permanent sterilization) must commit to the use of an acceptable form of birth control for the duration of the study and for 30 days after completion of the study
  • Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments

Exclusion Criteria

  • Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration
  • Serious spinal conditions (to include cauda equina syndrome, infection, tumor, fracture, or severe osteoporosis [i.e., if taking Bisphosphonate or TNF-α blockers])
  • Previous spinal surgery at the same level other than microdiscectomy (e.g., laminectomy, fusion)
  • Planned concurrent surgical procedure
  • Identification of a dural tear during surgery unless it is well repaired (no evidence of CSF leak with Valsalva and no plan to restrict activity post-operatively)
  • Any injury to the nerve root occurring during surgery
  • Concurrent painful physical condition that may require analgesic treatment (such as an NSAID or opioid) in the postsurgical period for pain that is not strictly related to the spinal surgery and which may confound the postsurgical assessments
  • Comorbidity impacting current physical function or Investigator opinion that it may impact postsurgical rehabilitation
  • Allergy, hypersensitivity, or contraindication to any of the study medications (i.e., bupivacaine, oxycodone, morphine, hydromorphone, gabapentin, acetaminophen, celecoxib, or cyclobenzaprine) for which an alternative medication is not provided in the protocol
  • Use of any of the following medications within the times specified before surgery
    • Long-acting opioid medication daily for more than 3 months duration or within 3 days of surgery, eg,
      • Morphine including MS Contin®
      • Hydromorphone [Dilaudid®]
      • Oxycodone [Oxycontin®]
      • Methadone
    • NSAIDs, except for low-dose aspirin used for cardioprotection within 3 days
    • Any opioid medication within 24 hours 
    • Short-acting opioids or NSAIDs should be at a steady or plateau dose
      • Should require or receive no more than 20 morphine equivalents (eg, 4 Percocet) within 24 hours of surgery
  • Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain
    • Selective serotonin reuptake inhibitors (SSRIs)
    • Selective norepinephrine reuptake inhibitors (SNRIs)
    • Duloxetine (Cymbalta)
      • If taking one of these medications for a reason other than pain control, there must be a stable dose for at least 1 month prior to study drug administration
      • Gabapentin (Neurotin) or pregabalin (Lyrica) permitted pre-operatively if the duration has been less than 12 weeks
  • Current use of systemic glucocorticosteroids within 1 month of enrollment in this study
  • Use of dexmedetomidine HCl (Precedex) within 3 days of study drug administration
  • History of coronary or vascular stent placed within the past 3 months (may be extended to 1 year if medically indicated per physician discretion)
  • Has been treated for a deep vein thrombosis, pulmonary embolism, myocardial infarction, or ischemic stroke within the past 6 months (may be extended to 1 year if medically indicated per physician discretion)
  • Severely impaired renal (e.g., serum creatinine clearance ≤ 30) or hepatic function (e.g., serum AST level >3 x ULN or serum ALT level >3 x ULN)
  • Any neurologic or psychiatric disorder that might impact postsurgical pain or interfere with study assessments
  • Malignancy in the last 2 years, per physician discretion
  • History of misuse, abuse, or dependence on opioid analgesics, other prescription drugs, illicit drugs, or alcohol
  • Dependence or chronic opioid use will be defined as use of more than 30 morphine equivalents per day during the prior 90 days
  • Failure to pass the urine drug screen or alcohol breath test
  • Body weight <50 kg (110 pounds) or a body mass index >40 kg/m2
  • Subjects receiving Worker's compensation for a disability or who are involved in litigation
  • Previous participation in an EXPAREL study
  • Administration of an 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 participation in this study

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Ahmad Nassr, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Non-cancer trials contact form

Phone: 800-664-4542 (toll-free)

International patient clinical studies questions