PK Study of EXPAREL in Subjects Undergoing Open Spinal Fusion or Reconstructive Surgery

• Status: Completed
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to characterize the pharmacokinetic (PK) profile of EXPAREL when administered via local wound infiltration to subjects undergoing open spinal fusion or reconstructive surgery.

The secondary objectives of this study are to assess the safety, tolerability, and efficacy of EXPAREL in this surgical model.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pacira Pharmaceuticals, Inc

Criteria

Inclusion Criteria:

1. Males or females ≥18 years of age.

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

3. Scheduled to undergo primary, ≥3 level cervical or thoracic spine fusion or reconstruction under general anesthesia. The surgical incision must be at least 8 cm in length.

4. Female subject 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, transdermal, or combination oral contraceptive approved by the FDA for greater than 2 months prior to screening and 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.

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

Exclusion Criteria:

1. History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics or opioids.

2. Contraindication to bupivacaine.

3. Received bupivacaine or any other local anesthetic within 7 days of screening.

4. Receiving workers' compensation.

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

6. Non-structural or acute spinal conditions (e.g., cauda equina syndrome, infection, tumor, fracture).

7. Planned concurrent surgical procedure.

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

9. Body weight <50 kg (110 pounds) or a body mass index ≥45 kg/m2.

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

11. 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).

12. Severely impaired renal or hepatic function (e.g., serum creatinine level > 2 mg/dL [176.8 μmol/L], blood urea nitrogen level >50 mg/dL [17.9 mmol/L], serum aspartate aminotransferase [AST] level >3 times the upper limit of normal [ULN], or serum alanine aminotransferase [ALT] level > 3 times ULN).

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

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

15. History of misuse, abuse, or dependence on opioid analgesics, other prescription drugs, illicit drugs, or alcohol.

16. Failure to pass the alcohol breath test or urine drug screen.

17. Current or historical evidence of any clinically significant disease or condition, especially cardiovascular or neurological conditions that, in the opinion of the Investigator, may increase the risk of surgery or complicate the subject's postsurgical course.

18. Clinically significant medical or psychiatric disease that, in the opinion of the Investigator, would constitute a contraindication to participation in the study, or cause inability to comply with the study requirements.

19. Received any investigational drug within 30 days prior to study drug administration, and/or has planned administration of another investigational product or procedure during the subject's participation in this study.

20. Previous participation in an EXPAREL study.