Femoral Nerve Block With Liposome Bupivacaine for Postsurgical Analgesia Following Total Knee Arthroplasty
Summary
The primary objectives of Part 1 are to (1) evaluate three dose levels of liposome bupivacaine versus placebo with respect to the magnitude and duration of the analgesic effect achieved following single dose injection femoral nerve block with liposome bupivacaine, and (2) select a single therapeutic dose of liposome bupivacaine from the three dose levels to be tested in Part 2. Part 2: The primary objective of Part 2 is to compare the magnitude and duration of the analgesic effect of single injection femoral nerve block of a single dose level of liposome bupivacaine (selected from Part 1) with placebo (preservative-free normal saline).
Timeline
- Start
- 2012-09
- Primary completion
- 2013-12
- Completion
- 2013-12
Outcome
Met primary endpoint
registry analysis (superiority test); (Part 1) EXPAREL 133 mg vs (Part 1) Placebo; p = 0.0237; LSMD -103.3 (95% CI -192 to -14); ANCOVA NCT01683071 ↗
registry analysis (superiority test); (Part 2) EXPAREL 266 mg vs (Part 2) Placebo; p <0.0001; LSMD -96.5 (95% CI -144 to -49); ANCOVA NCT01683071 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupivacaine | Other / unclassified | 67 mg | Other |
| Subject | Bupivacaine | Other / unclassified | 133 mg | Other |
| Subject | Bupivacaine | Other / unclassified | 266 mg | Other |
Indications
No indication recorded.