MedTrace Logo

Phase 2B Upper Extremity Nerve Block Study

NCT03011333 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2026-03-02

Study results available
· View outcomes & findings →

Summary

This is a Phase 2B, randomized, assessor-blind, active- and saline placebo-controlled, multicenter study in subjects undergoing augmentation mammoplasty to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 when administered via ultrasound-guided lateral and medial pectoral nerve block before surgery.

Conditions

  • Postoperative Pain

Interventions

DRUG

HTX-011

HTX-011 (bupivacaine/meloxicam) via nerve block or instillation.

DRUG

Bupivacaine HCl without epinephrine

Bupivacaine HCl without epinephrine, 50 mg via nerve block.

DRUG

Saline Placebo

Saline placebo via nerve block.

Sponsors & Collaborators

  • Heron Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-14
Primary Completion
2018-02-01
Completion
2018-03-19

Countries

  • United States

Study Locations

More Related Trials

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 NCT03011333 on ClinicalTrials.gov