Phase 4, Controlled Study in Adult Subjects Undergoing Primary, 1-2 Level, Open Lumbar Spinal Fusion Surgery

• Status: Terminated
• Trial end date: 2017-10-30
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective: The primary objective of this study is to compare postsurgical pain control following local infiltration analgesia (LIA) with EXPAREL admixed with bupivacaine HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar posterior spinal fusion surgery.

Secondary Objectives: The secondary objectives of this study are to compare additional efficacy, safety, and health economic outcomes following LIA with EXPAREL admixed with bupivacaine HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar posterior spinal fusion surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pacira Pharmaceuticals, Inc
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

1. Male or female, at least 18 years of age at screening.

2. Primary surgical indication is lumbar pain, radiculopathy, disc degeneration, disc herniation, foraminal stenosis, or 1-2 level spondylolisthesis or deformity.

3. Scheduled to undergo primary, 1-2 level, open lumbar spinal fusion surgery under general anesthesia.

4. American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.

5. Female subjects must be surgically sterile; or at least 2 years postmenopausal; or have a monogamous partner who is surgically sterile; or practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or 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.

6. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.

Exclusion Criteria:

1. Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.

2. Serious spinal conditions (to include cauda equina syndrome, infection, tumor, fracture, or severe osteoporosis [ie, if taking Bisphosphonate or TNF-α blockers]).

3. Planned anterior or lateral incisions

4. Previous spinal surgery at the same level other than microdiscectomy or hemilaminectomy (eg, bi-lateral laminectomy, fusion).

5. Planned concurrent surgical procedure.

6. Identification of a dural tear during surgery will be an intra-operative exclusion unless it is well repaired (no evidence of cerebrospinal fluid [CSF] leak with Valsalva and no plan to restrict activity post-operatively). Any injury to the nerve root occurring during surgery will also be considered an intra-operative exclusion.

7. 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.

8. Comorbidity impacting current physical function or Investigator opinion that it may impact postsurgical rehabilitation.

9. Allergy, hypersensitivity, or contraindication to any of the study medications (ie, bupivacaine, oxycodone, morphine, hydromorphone, gabapentin, acetaminophen, or cyclobenzaprine) for which an alternative medication is not provided in the protocol.

10. Use of any of the following medications within the times specified before surgery:

long-acting opioid medication (eg, morphine including MS Contin®, hydromorphone [Dilaudid®], oxycodone [Oxycontin®], methadone) daily for more than 3 months duration or within 3 days of surgery. Patients receiving short-acting opioids or NSAIDs should be at a steady or plateau dose. Such patients should require or receive no more than 40 mg morphine (oral) equivalents (eg, approximately 5 mg oxycodone) within 24 hours of surgery.

11. 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), or duloxetine (Cymbalta®). If a subject is taking one of these medications for a reason other than pain control, he or she must be on a stable dose for at least 1 month prior to study drug administration.

12. Current use of systemic glucocorticosteroids within 1 month of enrollment in this study.

13. Use of dexmedetomidine HCl (Precedex®) within 3 days of study drug administration.

14. History of coronary or vascular stent placed within the past 3 months (may be extended to 1 year if medically indicated per physician discretion).

15. Have 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).

16. Severely impaired renal (eg, serum creatinine clearance ≤ 30) or hepatic function (eg, serum aspartate aminotransferase [AST] level >3 times the upper limit of normal [ULN] or serum alanine aminotransferase [ALT] level >3 x ULN).

17. Any neurologic or psychiatric disorder that might impact postsurgical pain or interfere with study assessments.

18. Malignancy in the last 2 years, per physician discretion.

19. History of misuse, abuse, or dependence on opioid analgesics, other prescription drugs, illicit drugs, or alcohol as defined in DSM-IV. Dependence or chronic opioid use will be defined as use of more than 30 morphine equivalents per day during the prior 90 days.

20. Failure to pass the alcohol breath test or urine drug screen positive for illicit drugs.

21. Body weight <50 kg (110 pounds) or a body mass index >44 kg/m2.

22. Subjects receiving Worker's compensation for a disability or who are involved in litigation.

23. Previous participation in an EXPAREL study.

24. 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 the subject's participation in this study.