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Evaluation of Liposomal Bupivacaine Compared to Usual Care and Its Effects on Pain for Cardiac Surgery

NCT04065919 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2020-02-06

No results posted yet for this study

Summary

Evaluation of Liposomal Bupivacaine Compared to Usual Care and its Effect on Pain for Cardiac Surgery

Conditions

  • Cardiothoracic Surgery

Interventions

DRUG

Liposomal bupivacaine

20mL EXPAREL+40mL bupivacaine 0.25% infiltrated into 5th intercostal space

DRUG

0.25% Bupivacaine with epinephrine

0.25% Bupivacaine with epinephrine at 1cc/kg total dose infiltrated into 5th intercostal space

Sponsors & Collaborators

  • Florida Heart and Lung Institute

    lead OTHER

Principal Investigators

  • Charles T Klodell, MD · Florida Heart and Lung Institute, HCA Physician Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2020-10-30
Completion
2020-11-30
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 NCT04065919 on ClinicalTrials.gov