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Bupivacaine HCl PK and Safety in Augmentation Mammoplasty

NCT03705065 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-12-07

No results posted yet for this study

Summary

This is a Phase 4, randomized, open-label study of bupivacaine HCl administered either by instillation into the surgical site or by injection into the surgical site in subjects undergoing bilateral submuscular augmentation mammoplasty under general anesthesia.

Conditions

  • Analgesia

Interventions

DRUG

Bupivacaine HCl

Bupivacaine HCl without epinephrine 0.25%, 60 mL (30 mL per pectoral pocket)

Sponsors & Collaborators

  • Heron Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-19
Primary Completion
2018-10-08
Completion
2018-11-05
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 NCT03705065 on ClinicalTrials.gov