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Liposomal Bupivacaine for Post-Cesarean Pain

Phase 4
Recruiting
Led By Antonio Gonzalez, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No recent or chronic opioid use
Patients between the ages of 18 and 45 presenting for cesarean delivery
Must not have
Need for additional surgery other than cesarean delivery +/- bilateral tubal ligation (e.g. hysterectomy, cystotomy)
Need for Magnesium sulfate therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will test the hypothesis that TAP blocks with liposomal bupivacaine will decrease postoperative pain and immobility more than TAP blocks with bupivacaine or saline when used as part of a multimodal analgesic regimen for post cesarean delivery.

Who is the study for?
This trial is for women aged 18-45 undergoing cesarean delivery without allergies to morphine or bupivacaine, no anxiety history, and no recent/chronic opioid use. They should be generally healthy (ASA-1 to ASA-3). Overweight individuals (BMI > 45), those needing magnesium sulfate therapy, additional surgeries beyond cesarean or whose newborns require intensive care are excluded.
What is being tested?
The study tests the effectiveness of a TAP block using Liposomal Bupivacaine (LB) versus standard Bupivacaine and steroids for post-cesarean pain relief. It aims to reduce opioid use by providing prolonged pain control with LB compared to short-term effects seen with traditional methods.
What are the potential side effects?
Potential side effects may include discomfort at injection site, possible nerve damage from needle placement during the TAP block procedure, allergic reactions to medications used, and less commonly systemic effects like heart or nervous system issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not used opioids recently or regularly.
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I am between 18 and 45 years old and will have a cesarean delivery.
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My health is good enough for surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need surgery beyond a C-section and possibly tying my tubes.
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I need Magnesium sulfate treatment.
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My BMI is over 45.
Select...
My newborn was admitted to the NICU.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
MME
Secondary study objectives
Assessment of functional recovery
Other study objectives
Self assessed recovery survey

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Liposomal BupivacaineExperimental Treatment2 Interventions
Patient will receive intrathecal morphine + TAP block with Liposomal bupivacaine and bupivacaine 0.25%
Group II: Control group (Bupivacaine)Active Control1 Intervention
Patient will receive intrathecal morphine and TAP block with plain bupivacaine.
Group III: Bupivacaine + dexamethasone and methylprednisoloneActive Control1 Intervention
Patient will receive intrathecal morphine + TAP block with only bupivacaine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liposomal bupivacaine (LB)
2017
N/A
~50

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,920 Previous Clinical Trials
3,031,330 Total Patients Enrolled
Antonio Gonzalez, MDPrincipal InvestigatorYale University
2 Previous Clinical Trials
260 Total Patients Enrolled

Media Library

Liposomal bupivacaine (LB) Clinical Trial Eligibility Overview. Trial Name: NCT04393207 — Phase 4
Opioid Use Disorder Research Study Groups: Control group (Bupivacaine), Liposomal Bupivacaine, Bupivacaine + dexamethasone and methylprednisolone
Opioid Use Disorder Clinical Trial 2023: Liposomal bupivacaine (LB) Highlights & Side Effects. Trial Name: NCT04393207 — Phase 4
Liposomal bupivacaine (LB) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04393207 — Phase 4
~46 spots leftby May 2025
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