Study in Adult Subjects Undergoing Posterolateral Thoracotomy (NCT03428984) | Clinical Trial Compass
TerminatedPhase 1
Study in Adult Subjects Undergoing Posterolateral Thoracotomy
Stopped: Slow study enrollment
United States5 participantsStarted 2018-05-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.