Evaluate the Safety and Efficacy of EXPAREL When Administered Via Infiltration Into the TAP vs. Bupivacaine Alone in Subjects Undergoing Elective C-Sections

Launched by PACIRA PHARMACEUTICALS, INC · Jun 1, 2017

Keywords

ClinConnect Summary

This is a Phase-4, multicenter, randomized, double-blind, active-controlled study planned in approximately 152 adult subjects undergoing elective C-section. All subjects will remain in the hospital for up to 72 hours postsurgery.

Screening:

Subjects will be screened within 30 days prior to surgery; screening on the day of surgery will be allowed but is discouraged. During the screening visit, subjects will be assessed for any past or present medical conditions that in the opinion of the investigator would preclude them from study participation. After the informed consent form (ICF) is sig...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Females 18 years of age and older at screening.
• • 2. Term pregnancies of 37 to 42 weeks gestation, scheduled to undergo elective C-section.
• • 3. American Society of Anesthesiology (ASA) physical status 1, 2, or 3.
• • 4. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.
• Exclusion Criteria:
• • 1. Subjects who, in the opinion of the study site principal investigator, have a high-risk pregnancy (eg, multiple gestations, pregnancy resulting from in vitro fertilization, gestational diabetes, end-term prolonged bed rest required for medical reasons).
• • 2. Subjects with a pregnancy-induced medical condition or complication (eg, hypertension, pre-eclampsia, chorioamnionitis).
• • 3. Subjects with 3 or more prior C-sections.
• • 4. Pre-pregnancy body mass index \>50 kg/m2 or otherwise not anatomically appropriate to undergo a TAP block.
• • 5. Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (eg, amide-type local anesthetics, opioids, bupivacaine, NSAIDs, spinal anesthesia).
• • 6. Planned concurrent surgical procedure with the exception of salpingo-oophorectomy or tubal ligation.
• • 7. 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 the ULN.)
• • 8. Subjects at an increased risk for bleeding or a coagulation disorder (defined as platelet count less than 80,000 × 103/mm3 or international normalized ratio greater than 1.5)
• • 9. Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the postsurgical period for pain that is not strictly related to the surgery and which may confound the postsurgical assessments.
• • 10. Clinically significant medical disease in either the mother or baby that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes any psychiatric or other disease in the mother that would constitute a contraindication to participation in the study or cause the mother to be unable to comply with the study requirements.
• • 11. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
• • 12. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
• 13. Previous participation in an EXPAREL study. In addition, the subject will be ineligible to receive study drug and will be withdrawn from the study if she meets the following criteria during surgery:
• • 14. Any clinically significant event or condition uncovered during the surgery (eg, excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course.
• • 15. Receives the epidural component of CSE anesthesia during participation in the study.