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Local Anesthetic

Liposomal Bupivacaine + Standard Bupivacaine for Post-C-Section Pain

Phase 4
Waitlist Available
Led By Amy Boardman, MD
Research Sponsored by Atrium Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects at 37 completed weeks of gestation or greater undergoing elective primary or repeat cesarean delivery (CD)
Regional spinal anesthesia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours
Awards & highlights

Study Summary

This trial compares the effect of two types of anesthetic drugs on pain relief after c-section delivery.

Who is the study for?
This trial is for women over 18, at least 37 weeks pregnant, having an elective cesarean with spinal anesthesia. They must be healthy enough for surgery (ASA I-III), able to consent, and speak English or Spanish. Excluded are those with drug interactions, bleeding risks, severe organ dysfunction, chronic pain disorders not related to surgery, or a history of substance abuse within the last two years.Check my eligibility
What is being tested?
The study compares the effectiveness of EXPAREL® (liposomal bupivacaine) combined with bupivacaine HCl versus just bupivacaine HCl in managing postoperative pain after a cesarean section. The goal is to see if adding liposomal bupivacaine reduces opioid use after surgery.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site like numbness or tingling sensations due to nerve blockage from local anesthetics. There may also be low blood pressure or heart rate changes and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 37 weeks pregnant or more and scheduled for a cesarean delivery.
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I will receive spinal anesthesia in a specific region.
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My health is good to moderately impaired.
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I speak English or Spanish.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Amount of total opioid MME (milligram morphine equivalents) consumed at 24, 48 and 72hrs post-op
Secondary outcome measures
Initiation of breastfeeding
Length of hospital stay
Numeric Pain Rating Score at 72 hours Postoperative
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Liposomal Bupivacaine + Bupivacaine HCLExperimental Treatment2 Interventions
Liposomal bupivacaine + bupivacaine HCl surgical-site incision infiltration following spinal anesthesia
Group II: Bupivacaine HCl surgical-site incision infiltrationActive Control1 Intervention
Bupivacaine HCl surgical-site incision infiltration following spinal anesthesia
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liposomal bupivacaine
2016
Completed Phase 4
~1970
Bupivacaine HCl
2008
Completed Phase 4
~3510

Find a Location

Who is running the clinical trial?

Atrium HealthLead Sponsor
121 Previous Clinical Trials
34,854 Total Patients Enrolled
1 Trials studying Postoperative Pain
72 Patients Enrolled for Postoperative Pain
Wake Forest University Health SciencesLead Sponsor
1,240 Previous Clinical Trials
1,004,207 Total Patients Enrolled
3 Trials studying Postoperative Pain
246 Patients Enrolled for Postoperative Pain
Amy Boardman, MDPrincipal InvestigatorWake Forest University Health Sciences

Media Library

Bupivacaine HCl (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT04232306 — Phase 4
Postoperative Pain Clinical Trial 2023: Bupivacaine HCl Highlights & Side Effects. Trial Name: NCT04232306 — Phase 4
Bupivacaine HCl (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04232306 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Liposomal Bupivacaine + Bupivacaine HCL an unsafe option for patients?

"With a rating of 3, the safety of Liposomal Bupivacaine + Bupivacaine HCL is estimated to be high due to this treatment having reached Phase 4 trial and being approved."

Answered by AI

Is enrollment for this research endeavor still open?

"As indicated on clinicaltrials.gov, this particular trial is not presently seeking participants. Initially posted in October of 2023 and recently updated in April of the same year, no further recruitment efforts are necessary at present. However, there are 636 other studies looking for enrollees as we speak."

Answered by AI

Could you provide additional details about the results of prior experiments utilizing Liposomal Bupivacaine + Bupivacaine HCL?

"Presently, 97 clinical trials are underway for the combination drug Liposomal Bupivacaine + Bupivacaine HCL. Of those studies, 15 are in their concluding phase (Phase 3). The majority of these tests originate from Philadelphia, Pennsylvania, yet there exists a total of 131 separate sites running trials."

Answered by AI

In what medical conditions can Liposomal Bupivacaine + Bupivacaine HCL be applied to alleviate symptoms?

"Liposomal Bupivacaine + Bupivacaine HCL is often prescribed to treat pemphigus. Additionally, this medication can be employed for acute nonspecific tenosynovitis, general anesthesia, and lupus erythematous cell ailments as well."

Answered by AI

What is the cap on enrollment for this clinical trial?

"This study is no longer recruiting, as the last update was on April 20th of this year. If you are looking for other opportunities to participate in a clinical trial related to postoperative pain, there are 539 trials that need your help. Additionally, 97 studies require volunteers specifically interested in Liposomal Bupivacaine + Bupivacaine HCL treatments."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Liposomal Bupivacaine + Bupivacaine vs. Bupivacaine Alone on Opioid Use After Elective c/Section
Amy Boardman, MD 2024. "Liposomal Bupivacaine + Bupivacaine vs. Bupivacaine Alone on Opioid Use After Elective c/Section". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04232306.
~0 spots leftby Dec 2025
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