Evaluation of the Safety and Efficacy of EXPAREL When Administered Into the TAP in Subjects Undergoing Cesarean Section

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

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).

Study Overview

• Status: Terminated
• Conditions: Pain
• Intervention / Treatment: Drug: Intrathecal morphine injection; Drug: EXPAREL

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).

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Port Saint Lucie, Florida, United States, 34987
      • Tradition Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Saint Peter's University Hospital
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University, Wexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; 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.	Drug: Intrathecal morphine injection; 0.2 mg; Other Names: Duramorph
Experimental: EXPAREL/TAP; Subjects in Group 2 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).	Drug: EXPAREL; 266 mg; Other Names: Bupivacaine liposome injectable suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Postsurgical Narcotic Consumption in Morphine Equivalents	Outcome measure data refer to 7 participants who received rescue medication	Through 72 hours postdose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Postsurgical Narcotic Consumption in Morphine Equivalents	Outcome measure data refer to 6 participants who received rescue medication	Through 24 hours
Total Postsurgical Narcotic Consumption in Morphine Equivalents	Outcome measure data refer to 7 participants who received rescue medication	Through 48 hours

Collaborators and Investigators

• Sponsor: Pacira Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: January 28, 2015
• First Submitted That Met QC Criteria: January 29, 2015
• First Posted (Estimate): February 3, 2015

Study Record Updates

• Last Update Posted (Actual): March 26, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bupivacaine; Morphine
• Other Study ID Numbers: 402-C-402