Clinical trial NCT02353754: Evaluation of the Safety and Efficacy of EXPAREL When Administered Into the TAP in Subjects Undergoing Cesarean Section
Official title: A Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of EXPAREL When Administered Via Infiltration Into the Transversus Abdominis Plane (TAP) After Bupivacaine Spinal Anesthesia in Subjects Undergoing Elective Cesarean Section
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2015-02-03
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 4, multicenter, open-label study evaluating EXPAREL infiltration into the transversus abdominis plane (TAP) after bupivacaine hydrochloride (HCl) spinal anesthesia in subjects undergoing elective Cesarean section (C-section).

Detailed description: There will be two groups of subjects with approximately 40 subjects per group. Prior to the C-section, all subjects will receive single-shot spinal anesthesia (1.5 mL bupivacaine HCl 0.75% with dextrose 8.25%). Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered. Subjects in Group 2 (EXPAREL/TAP) will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).

Eligibility criteria: Inclusion Criteria:

1. Females ≥18 years of age at screening.
2. Scheduled to undergo elective C-section (single or multiple births).
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. History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics or opioids.
2. Contraindication to bupivacaine, morphine, ketorolac, ibuprofen, or acetaminophen.
3. Planned concurrent surgical procedure with the exception of salpingo-oophorectomy or tubal ligation.
4. Use of any of the following medications within the times specified before surgery: long-acting opioid medication, non-steroidal anti-inflammatory drugs (NSAIDs), or aspirin (except for low-dose aspirin used for cardioprotection) within 3 days, or any opioid medication or acetaminophen within 24 hours.
5. Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®). If a subject is taking one of these medications for a reason other than pain control, she must be on a stable dose for at least 1 month prior to study drug administration.
6. Clinically significant medical or psychiatric disease that, in the opinion of the Investigator, would constitute a contraindication to participation in the study or cause inability to comply with the study requirements.
7. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medication(s), or alcohol within the past 2 years.
8. Received an investigational drug within 30 days prior to study drug administration, and/or has planned administration of another investigational product or procedure while participating in this study.
9. Previous participating in an EXPAREL study.

   The subject will be withdrawn from the study if she meets the following criteria:
10. Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course.
11. Her baby's 5-minute Apgar score is ≤7.

Primary outcomes:
measure: Total Postsurgical Narcotic Consumption in Morphine Equivalents
timeFrame: Through 72 hours postdose
Secondary outcomes:
measure: Total Postsurgical Narcotic Consumption in Morphine Equivalents
timeFrame: Through 24 hours
measure: Total Postsurgical Narcotic Consumption in Morphine Equivalents
timeFrame: Through 48 hours
Other outcomes:
Locations:
city: Port Saint Lucie
country: United States
facility: Tradition Medical Center
state: Florida
city: Minneapolis
country: United States
facility: University Of Minnesota
state: Minnesota
city: New Brunswick
country: United States
facility: Saint Peter's University Hospital
state: New Jersey
city: Bronx
country: United States
facility: Montefiore
state: New York
city: Columbus
country: United States
facility: The Ohio State University, Wexner Medical Center
state: Ohio
Study officials:
affiliation: Pacira Pharmaceuticals, Inc
name: Erol Onel, MD
role: STUDY_DIRECTOR
References: