Study in Adult Subjects Undergoing Posterolateral Thoracotomy

Stopped early · Phase 1

Conditions studied: Postoperative Pain Management

In brief

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.

Key facts

Study ID

NCT03428984

Run by

Pacira Pharmaceuticals, Inc

People needed

5

Starts

2018-05-03

Expected to finish

2018-09-28

Last updated by the study team

2019-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females ≥18 years of age.
• American Society of Anesthesiologists (ASA) physical status 1, 2, or 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.
• Able to provide informed consent, adhere to the study schedule, and complete all study assessments.

You may not qualify if…

• 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.
• 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.
• Any planned pleurodesis as part of the surgical procedure.
• Redo ipsilateral thoracotomy
• Received bupivacaine or any other local anesthetic within 7 days of screening.
• Body weight < 50 kilograms (110 pounds) or a body mass index ≥ 35 kg/m2.
• History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics or opioids.
• Previous participation in a liposome bupivacaine study.
• History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
• Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance.
• 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.
• History of coronary or vascular stent placed within the past 3 months (may be extended to 1 year if medically indicated per physician discretion).
• 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).
• 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).

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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