Status:
TERMINATED
Study in Adult Subjects Undergoing Posterolateral Thoracotomy
Lead Sponsor:
Pacira Pharmaceuticals, Inc
Conditions:
Postoperative Pain Management
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Detailed Description
This is a Phase 1, single-center, open-label study designed to evaluate the safety and PK profile of EXPAREL when administered as a posterior intercostal nerve block. Twenty-four adult subjects underg...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2018
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03428984
Start Date
May 3 2018
End Date
September 28 2018
Last Update
February 6 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030