A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Efficacy… in Subjects Undergoing Total Knee Arthroplasty [Protocol No.: 402-C-323]

Service: Trial Number:
153-12
Principal Investigator: Conducted at:
Saddleback Memorial - Laguna Hills
Currently enrolling additional patients:
Yes

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Single Injection Femoral Nerve Block with Liposome Bupivacaine for Postsurgical Analgesia in Subjects Undergoing Total Knee Arthroplasty [Protocol No.: 402-C-323]. According to numerous literary sources, effective postsurgical pain control is a critical element in patient recovery following surgery. Improved postsurgical pain management contributes to better healing, faster subject mobilization, shortened hospital stays, and reduced healthcare costs. Liposome bupivacaine (EXPAREL®) could provide good, continuous and longer pain relief around the knee, which could lower the amount of other medicines (opiate analgesics or non-opiate analgesics) needed to treat postsurgical pain. This can possibly reduce a patient’s chances of nausea, vomiting and may lead to an earlier recovery time, earlier discharge, and return to normal activities. This is a Phase 2/3, multicenter, randomized, double-blind, parallel-group, placebo-controlled, dose-ranging study in subjects undergoing primary unilateral total knee arthroplasty (TKA) under general or spinal anesthesia. Subjects will be appropriately screened by study staff to determine eligibility. If eligible, the subjects will proceed with presentation to the hospital for elective unilateral TKA surgery.

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