At a glance
ClinicalIndex Comparison Record- ✓Scheduled for primary bilateral submuscular augmentation mammoplasty with saline or silicone smooth implants 300–500 cc
- ✓ASA physical status I, II, or III
- ✓Not pregnant, not lactating, not planning pregnancy during study, or using acceptable contraception
- ✕Concurrent surgical procedure planned
- ✕Planned reconstructive procedure post-breast cancer therapy
- ✕Pre-existing acute or chronic painful condition requiring postoperative analgesia
- ✕Contraindication or hypersensitivity to study medications
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2B, Randomized, Controlled Study of HTX-011 Administered Via Pectoral Nerve Block in Subjects Undergoing Upper Extremity Surgery for Augmentation Mammoplasty
In Brief
A Phase 2 clinical trial evaluating HTX-011, Bupivacaine HCl without epinephrine, and 1 other intervention for Postoperative Pain. Completed, enrolled 243 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
HTX-011 (bupivacaine/meloxicam) via nerve block or instillation.
Bupivacaine HCl without epinephrine, 50 mg via nerve block.
Saline placebo via nerve block.