Ensayos clínicos

Inclusion Criteria:

• 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 cohort 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.

Exclusion Criteria:

• 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 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: 
  • 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); 
  • 2 or more medications for postoperative nausea, vomiting, or pruritus (e.g., dexamethasone, ondansetron).
• History of severely impaired renal or hepatic function. 
• Severe chronic pain that requires analgesic treatment, and in the opinion of the principal Investigator, is likely to meaningfully impact postsurgical outcomes.
• Subjects that have implanted spinal cord stimulator or intrathecal drug pump. 
• Any neurologic or psychiatric disorder that might impact 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 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 < 17 kg/m2 or > 44 kg/m^2 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.