The Effect of Liposomal Bupivacaine Plus Bupivacaine Versus Bupivacaine Alone on Postoperative Opioid Use After Elective Cesarean Delivery: a Randomized Control Trial

IRB00081325

The purpose of this study is to compare the effectiveness of local wound infiltration of EXPAREL® (liposomal bupivacaine) with bupivacaine HCl compared to active control with bupivacaine HCl alone following elective primary or repeat cesarean delivery with spinal anesthesia.

2024-03-01

2025-12-01

2025-12-01

Withdrawn

Early phase I

Inclusion Criteria: * Females 18 years of age and older at screening * Subjects at 37 completed weeks of gestation or greater undergoing elective primary or repeat cesarean delivery (CD) * Pfannenstiel incision * Regional spinal anesthesia * ASA classification I, II, or III * Able to give informed consent * English- or Spanish-speaking Exclusion Criteria: * ASA classification IV * 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). * Potential drug interaction(s) with bupivacaine * Severe renal or hepatic dysfunction manifest as serum creatinine level \>2 mg/dL, blood urea nitrogen level \>50 mg/dL , serum aspartate aminotransferase level \>3 times the upper limit of normal, or serum alanine aminotransferase level \>3 times the ULN. * Any clinically significant maternal or fetal event or condition arising during surgery (eg, excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course. In this situation, the subject would be ineligible to receive study drug and withdrawn from the study. * Chronic pain disorder manifest as a concurrent, painful, physical condition that may require long-term, consistent use of opioids postoperatively for pain that is not strictly related to the surgery and may confound postsurgical assessments. * History of, suspected, or known addiction or abuse of illicit drug(s) or prescription medication(s) within the past 2 years. * Planned concurrent surgical procedure except for salpingo-oophorectomy or tubal ligation. * Subject at increased risk for bleeding or coagulation disorder (defined as platelet count less than 80,000/mm3 or international normalized ratio\[INR\] greater than 1.5). * Pregnancy body mass index \>50 kg/m2 or otherwise not anatomically appropriate to undergo local incision infiltration. * Conversion of spinal anesthesia to general anesthesia due to incomplete neuraxial block and unsatisfactory surgical anesthesia.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized, single-blind, active-controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Patients will be blinded to treatment arm to which patients are assigned.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2024-04-10