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Pecto-Intercostal Fascial Plane Block Study

NCT04928339 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-11-19

Study results available
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Summary

This study is being done to see if bilateral pecto-intercostal fascial plane blocks (PIFB) with a mixture of liposomal and standard bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline). 100 participants will be recruited and can expect to be on study for 100 days.

Conditions

  • Cardiac Surgery
  • Opioid Use, Unspecified

Interventions

DRUG

Bupivacaine Injection

10mL of 0.25% bupivacaine

DRUG

Liposomal bupivacaine

15mL of 133mg liposomal bupivacaine

OTHER

Saline

25mL saline control

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Patrick Meyer, MD · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-28
Primary Completion
2023-09-03
Completion
2023-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04928339 on ClinicalTrials.gov