Trials / Completed
CompletedNCT03011333
Phase 2B Upper Extremity Nerve Block Study
A Phase 2B, Randomized, Controlled Study of HTX-011 Administered Via Pectoral Nerve Block in Subjects Undergoing Upper Extremity Surgery for Augmentation Mammoplasty
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 243 (actual)
- Sponsor
- Heron Therapeutics · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-01-14
- Primary completion
- 2018-02-01
- Completion
- 2018-03-19
- First posted
- 2017-01-05
- Last updated
- 2026-03-02
- Results posted
- 2021-10-29
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03011333. Inclusion in this directory is not an endorsement.