drugset / Trial / NCT03907176
Study of Post-Herniorrhaphy Non-opioid MMA Regimens
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase 3b, open-label study to assess postoperative opioid use in subjects undergoing unilateral open inguinal herniorrhaphy with intraoperative administration of HTX-011 and a postoperative non-opioid multimodal analgesic (MMA) regimen. The study will be conducted in 2 sequential parts: Part 1 is randomized and Part 2 is Investigator's preference for MMA regimen.
Timeline
- Start
- 2019-04-04
- Primary completion
- 2021-10-25
- Completion
- 2021-11-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 1 g | — |
| Subject | Ibuprofen | Small molecule | 600 mg | — |
| Background | Bupivacaine | Other / unclassified | 300 mg | Other |
| Background | Meloxicam | Small molecule | 9 mg | Other |
Indications
No indication recorded.