drugset / Trial / NCT01683071

Femoral Nerve Block With Liposome Bupivacaine for Postsurgical Analgesia Following Total Knee Arthroplasty

NCT01683071

Phase 2/3 Completed 297 enrolled Pacira Pharmaceuticals, Inc
RandomizedParallel-groupTriple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
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.