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Fascial Plane Block for Cardiac Surgery and Opioid Use Disorder

Phase 4
Waitlist Available
Led By Patrick Meyer, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 90 days post-op
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Study Summary

This trial is testing a new pain relief method for heart surgery patients that could potentially decrease the amount of pain medication needed. 100 patients will be involved, and the trial will last 100 days.

Eligible Conditions
  • Cardiac Surgery
  • Opioid Use Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 days post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days post-op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Total Opioid Consumption 72 hours postoperatively
Secondary outcome measures
Daily Mean Pain Scores first 72 hours Postoperatively
Daily Opioid Consumption up to 72 hours Postoperatively
Hours of Mechanical Ventilation after ICU admission
+8 more

Awards & Highlights

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

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PIFB interventionExperimental Treatment2 Interventions
bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL)
Group II: Saline ControlPlacebo Group1 Intervention
bilateral PIFB with 25 mL saline only
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine Injection
2017
Completed Phase 4
~450
Liposomal bupivacaine
2016
Completed Phase 4
~1970

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,139 Previous Clinical Trials
2,946,498 Total Patients Enrolled
Patrick Meyer, MDPrincipal InvestigatorUniversity of Wisconsin, Madison

Media Library

Liposomal bupivacaine Clinical Trial Eligibility Overview. Trial Name: NCT04928339 — Phase 4
Cardiac Surgery Research Study Groups: PIFB intervention, Saline Control
Cardiac Surgery Clinical Trial 2023: Liposomal bupivacaine Highlights & Side Effects. Trial Name: NCT04928339 — Phase 4
Liposomal bupivacaine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04928339 — Phase 4

Frequently Asked Questions

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

Are there any prior investigations that have explored the efficacy of Liposomal bupivacaine?

"Presently, 109 trials concerning liposomal bupivacaine are ongoing with 18 being at the critical Phase 3 stage. While Philadelphia is a major contributor to research in this field, there are 144 sites across North America running studies for it."

Answered by AI

Are there any opportunities to become a participant in this experiment?

"Indeed, according to information on clinicaltrials.gov, this experiment is actively recruiting patients. As of October 4th 2022, the study has been open since March 28th 2020 and needs 100 individuals at a single site."

Answered by AI

What is the regulatory status of Liposomal bupivacaine?

"Based on the Phase 4 status of Liposomal bupivacaine, our team at Power assessed its safety as a 3. This medication has already been approved for use in medical settings."

Answered by AI

What is the scope of patient recruitment for this research endeavor?

"Yes, according to the clinicaltrials.gov database, this medical study is currently seeking participants. It was first posted on March 28th 2022 and updated most recently on October 4th of that same year. The trial necessitates 100 patients from one single site for successful completion."

Answered by AI

What type of ailments can Liposomal bupivacaine be employed to alleviate?

"Liposomal bupivacaine is most commonly prescribed for permphigus, yet it has also proven effective in managing acute nonspecific tenosynovitis, general anesthesia, and lupus erythematosus cell."

Answered by AI

Is geriatric participation welcome in this investigation?

"This study is seeking participants that are within the age range of 18 and 80 years old."

Answered by AI

What are the requirements for enrolment into this trial?

"Patients wishing to be included in this medical trial must have had surgery, a clean bill of cardiac health and fit within the age bracket 18-80. Approximately 100 participants are expected."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pecto-Intercostal Fascial Plane Block Study
2022. "Pecto-Intercostal Fascial Plane Block Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04928339.
~37 spots leftby Nov 2024
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