Liposomal Bupivacaine + Bupivacaine vs. Bupivacaine Alone on Opioid Use After Elective c/Section

NCT04232306 | Withdrawn Phase 4 FDA Drug

• 2 other identifiers: IRB00081325Pro00022425
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain; Cesarean Section

Keywords

Postoperative analgesia; Postoperative opioid use

Outcome Measures

Primary Outcomes (1)

• Amount of total opioid MME (milligram morphine equivalents) consumed at 24, 48 and 72hrs post-op

  3.1 To compare total opioid consumption through 72-hours following EXPAREL® + bupivacaine HCl surgical-site infiltration versus bupivacaine HCl alone at elective primary or repeat cesarean delivery after spinal anesthesia. 3.2 Primary outcome of this study is total opioid consumption measured in milligram morphine equivalents (MME) at 24-, 48- and 72-hours postoperatively and total MME for duration of hospital admission.

  72 hours

Secondary Outcomes (6)

• time to initial rescue analgesia administration

  24 hours

• Numeric Pain Rating Score at 72 hours Postoperative

  72 hours

• Overall Benefit of Analgesia Score at 72 hours Postoperative

  72 hours

• Length of hospital stay

  72 hours

• Initiation of breastfeeding

  72 hours

Study Arms (2)

Liposomal Bupivacaine + Bupivacaine HCL

EXPERIMENTAL

Liposomal bupivacaine + bupivacaine HCl surgical-site incision infiltration following spinal anesthesia

Drug: Liposomal bupivacaine; Drug: Bupivacaine HCl

Bupivacaine HCl surgical-site incision infiltration

ACTIVE COMPARATOR

Bupivacaine HCl surgical-site incision infiltration following spinal anesthesia

Drug: Bupivacaine HCl

Interventions

Liposomal bupivacaine DRUG

Bupivacaine liposome injectable suspension

Also known as: Exparel

Liposomal Bupivacaine + Bupivacaine HCL

Bupivacaine HCl DRUG

Bupivacaine HCl surgical-site incision infiltration

Also known as: Bupivacaine

Bupivacaine HCl surgical-site incision infiltration; Liposomal Bupivacaine + Bupivacaine HCL

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligibility based on gender female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health

Charlotte, North Carolina, 28203, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Amy Boardman, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be blinded to treatment arm to which patients are assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, single-blind, active-controlled trial

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: January 18, 2020
• Study Start: March 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)