Study in Adult Subjects Undergoing Posterolateral Thoracotomy

NCT03428984 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: 402-C-118
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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 EXPAREL in this surgical model.

Conditions

Postoperative Pain Management

Outcome Measures

Primary Outcomes (1)

• AUC of EXPAREL concentration

  Area under the concentration curve for EXPAREL

  0-72 hours

Secondary Outcomes (1)

• Incidence of treatment-emergent adverse events

  0-14 days

Study Arms (2)

EXPAREL 20 + 20

EXPERIMENTAL

20 mL EXPAREL with 20 mL normal saline

Drug: EXPAREL

EXPAREL 20 + 10

EXPERIMENTAL

20 mL EXPAREL with 10 mL normal saline

Drug: EXPAREL

Interventions

EXPAREL DRUG

EXAPREL 266 mg in 20 mL

EXPAREL 20 + 10; EXPAREL 20 + 20

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Study Officials

• David Rice, MD

  MD Anderson

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 12, 2018
• Study Start: May 3, 2018
• Primary Completion: September 28, 2018
• Study Completion: September 28, 2018
• Last Updated: February 6, 2019

Record last verified: 2019-02

Locations

US (1)