Phase 4
Completed N=167
Efficacy and Safety of EXPAREL Versus Standard of Care (SoC) in Subjects Undergoing Elective Cesarean Section
Elective Cesarean Section · Pain Management
Source: ClinicalTrials.gov NCT03853694 ↗
Enrolled (actual)
167
Serious AEs
3.9%
Results posted
Jul 2022
Primary outcomePrimary: Total Postsurgical Opioid Consumption Through 72 Hours — 69.3; 36.1; 22.1 OMED mg
◆ Published Evidence
Established
26citations · ~5 / year
Randomized trial of transversus abdominis plane block with liposomal bupivacaine after cesarean delivery with or without intrathecal morphine.
Summary
The purpose of this study is to compare total opioid consumption by subjects in different treatment groups.
Another purpose of this study is to assess how well EXPAREL works, collect any safety data and assess your satisfaction using EXPAREL.
Linked Publications
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Randomized trial of transversus abdominis plane block with liposomal bupivacaine after cesarean delivery with or without intrathecal morphine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Postsurgical Opioid Consumption Through 72 Hours |
69.3; 36.1; 22.1 | — |
| SECONDARY Percentage of Opioid-free Subjects |
22.4; 28.8; 30 | — |
| SECONDARY Severity of Itching (Numeric Rating Scale Score) |
1.48; 0.94; 0.61 | — |
| SECONDARY Opioid Related Symptom Distress Scale Score (ORSDS) |
0.33; 0.23; 0.35 | — |
Eligibility Criteria
Inclusion Criteria
- Females 18 years of age and older at screening.
- Term pregnancies of 37 to 42 weeks gestation, scheduled to undergo elective C-section.
- American Society of Anesthesiology (ASA) physical status 1, 2, or 3.
- Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.
Exclusion Criteria
- Subjects who, in the opinion of the study site principal investigator, have a high-risk pregnancy.
- Subjects with a pregnancy-induced medical condition or complication.
- Subjects with 3 or more prior C-sections.
- Pre-pregnancy body mass index >50 kg/m2.
- Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications.
- Planned concurrent surgical procedure with the exception of salpingo-oophorectomy or tubal ligation.
- Severely impaired renal or hepatic function.
- Subjects at an increased risk for bleeding or a coagulation disorder.
- Concurrent painful physical condition that may require analgesic treatment in the postsurgical period for pain that is not strictly related to the surgery.
- 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.
- History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
- Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug.
- Previous participation in an EXPAREL study.
- Any clinically significant event or condition uncovered during the surgery that might render the subject medically unstable or complicate the subject's postsurgical course.
- Receives the epidural component of combined spinal epidural (CSE) anesthesia during the study.
Data sourced from ClinicalTrials.gov (NCT03853694) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.