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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 hours

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 hours

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

MME

Secondary outcome measures

Assessment of functional recovery

Other outcome measures

Self assessed recovery survey

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,852 Previous Clinical Trials

2,738,141 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

Frequently Asked Questions

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

In what contexts is Liposomal bupivacaine (LB) typically employed?

"Liposomal bupivacaine (LB) is a viable option for treating conditions like Permphigus, acute nonspecific tenosynovitis and facilitating general anesthesia."

Answered by AI

How can I become a participant in this investigation?

"This clinical trial is seeking 200 qualified participants aged 18-45 with acute pain. Specifically, those who have a Body Mass Index (BMI) below 45, no history of anxiety or chronic opioid use, and are preparing for cesarean delivery will be considered eligible."

Answered by AI

Is there a risk of any adverse health outcomes when using Liposomal bupivacaine (LB)?

"Given that this is a Phase 4 trial, which implies the drug's approval and widespread usage, Liposomal bupivacaine (LB) was rated highly in terms of safety with a score of 3."

Answered by AI

What is the total enrollment capacity for this experiment?

"Affirmative. According to clinicaltrials.gov, this trial has been open since February 1st 2022 and is currently recruiting patients. 200 individuals will be admitted at one site in total."

Answered by AI

Is this research protocol open to seniors aged 60 or above?

"The age limits for this trial are 18 and 45, respectively. Therefore, any person wishing to participate must be within these two boundaries."

Answered by AI

Is the research team actively seeking participants in this experiment?

"Clinicaltrials.gov lists this clinical trial as actively recruiting participants, with the initial posting occurring on February 1st 2022 and the most recent update being made available August 15th of that same year."

Answered by AI

Can you provide more information on prior experiments involving Liposomal bupivacaine (LB)?

"Currently, Liposomal bupivacaine (LB) is being studied in 109 active clinical trials with 18 of those studies at the Phase 3 stage. Philadelphia, Pennsylvania serves as the primary research site for this medication; however, there are 144 sites across America that have begun their own investigations into Liposomal bupivacaine's efficacy."

Answered by AI

Recent research and studies

British Journal of AnaesthesiaJournal

Comparison of Transversus Abdominis Plane Block Vs Spinal Morphine for Pain Relief After Caesarean Section

McMorrow, R.C.N., R.J. Ni Mhuircheartaigh, K.A. Ahmed, A. Aslani, S.-C. Ng, I. Conrick-Martin, J.J. Dowling, A. Gaffney, J.P.R. Loughrey, and C.L. McCaul. 2011. “Comparison of Transversus Abdominis Plane Block Vs Spinal Morphine for Pain Relief After Caesarean Section”. British Journal of Anaesthesia. Elsevier BV. doi:10.1093/bja/aer061.

Annales Françaises d'Anesthésie et de RéanimationJournal

Réhabilitation périopératoire des césariennes programmées non compliquées en france : enquête de pratique nationale

Jacques, V., F. Vial, M. Lerintiu, N. Thilly, U. Mc Nelis, J. Raft, and H. Bouaziz. 2013. “Réhabilitation périopératoire des césariennes programmées non compliquées en france : enquête de pratique nationale”. Annales françaises d'anesthésie et de réanimation. Elsevier BV. doi:10.1016/j.annfar.2013.01.016.

Journal of Clinical AnesthesiaJournal

Ultrasound-guided Bilateral Transversus Abdominis Plane Blocks in Conjunction with Intrathecal Morphine for Postcesarean Analgesia

Lee, Allison J., Howard D. Palte, Jules Marie A. Chehade, Kristopher L. Arheart, Jayanthie S. Ranasinghe, and Donald H. Penning. 2013. “Ultrasound-guided Bilateral Transversus Abdominis Plane Blocks in Conjunction with Intrathecal Morphine for Postcesarean Analgesia”. Journal of Clinical Anesthesia. Elsevier BV. doi:10.1016/j.jclinane.2013.05.004.

Journal of Pain ResearchJournal