Efficacy of Liposomal Bupivacaine for Prolonged Postoperative Analgesia in Patient Undergoing Breast Reconstruction With Tissue Expander
Summary
Patients undergoing breast reconstruction with tissue expanders will be treated with a local anesthetic during their procedure and monitor their post-operative pain level and amount of oral pain medication taken. This information will be used to determine if liposomal bupivacaine provides better and longer pain control vs. bupivacaine HCl.
Timeline
- Start
- 2014-08-22
- Primary completion
- 2017-12-31
- Completion
- 2019-05-15
Outcome
Missed primary endpoint
registry analysis (superiority test); DepoFoam Bupivacaine vs Bupivacaine HCl; p = .87; Kruskal-Wallis NCT04278846 ↗
registry analysis (superiority test); DepoFoam Bupivacaine vs Bupivacaine HCl; p = .57; Kruskal-Wallis NCT04278846 ↗
registry analysis (superiority test); DepoFoam Bupivacaine vs Bupivacaine HCl; p = .99; Kruskal-Wallis NCT04278846 ↗
registry analysis (superiority test); DepoFoam Bupivacaine vs Bupivacaine HCl; p = .12; Kruskal-Wallis NCT04278846 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bupivacaine hydrochloride (HCl) | Unknown | — | Other |
| Subject | Depofoam bupivacaine | Unknown | — | Other |