Study in Adult Subjects Undergoing Posterolateral Thoracotomy

• Status: Terminated
• Trial end date: 2018-09-28
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective: To characterize the pharmacokinetic (PK) profile of EXPAREL when administered as a posterior intercostal nerve block.

Secondary Objective: To assess the safety and tolerability 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 chest surgery using either minimally invasive (VATS or robotic-assisted surgery) or open techniques (posterolateral, lateral, or anterior thoracotomy or requiring insertion of an inter-rib spreader/retractor) for a primary thoracic non-infectious indication under general anesthesia.

4. Able to provide informed consent, adhere to the study 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. Female subjects must be surgically sterile, at least 2 years menopausal, or using an acceptable method of birth control. If of childbearing potential, the subject must have a documented negative pregnancy test within 24 hours before surgery.

2. Prior ipsilateral thoracotomy (the likely presence of adhesions will limit ability to perform a precise block guided by thoracoscopy). Note: previous VATS or robotic surgery is permissible.

3. Any planned pleurodesis as part of the surgical procedure.

4. Redo ipsilateral thoracotomy

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

6. Body weight < 50 kilograms (110 pounds) or a body mass index ≥ 35 kg/m2.

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

8. Previous participation in a liposome bupivacaine study.

9. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.

10. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance.

11. Significant medical conditions (including widely disseminated metastatic disease) or laboratory results that, in the opinion of the investigator, indicate an increased vulnerability to study drugs and procedures.

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

13. 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).

14. Severely impaired renal or hepatic function (eg, 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).