drugset / Trial / NCT03705065
Bupivacaine HCl PK and Safety in Augmentation Mammoplasty
RandomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2018-09-19
- Primary completion
- 2018-10-08
- Completion
- 2018-11-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupivacaine | Other / unclassified | 0.25 % | Other |
| Subject | Bupivacaine | Other / unclassified | 60 ml | Other |
Indications
No indication recorded.