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Study to Evaluate the Pharmacokinetics and Safety of EXPAREL Administered as a Pectoral Plane Block in Women Undergoing Breast Augmentation

NCT04293809 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-01-29

No results posted yet for this study

Summary

This is a pilot, open label, single center study in 30 women undergoing breast augmentation. The study will assess and collect information on pharmacokinetics and safety of EXPAREL administered as a pectoral plane block.

A total of 15 subjects will be enrolled in each of the 2 cohorts.

Conditions

  • Breast Augmentation

Interventions

DRUG

Exparel Injectable Product

bupivacaine liposome injectable suspension

DRUG

Bupivacaine Hydrochloride

1.3%, 13.3 mg/mL

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Nayana Nagaraj, MD, PhD, MPH · Pacira Pharmaceuticals, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-19
Primary Completion
2020-01-15
Completion
2020-01-29
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 NCT04293809 on ClinicalTrials.gov