Participants in this phase 3, multicenter, randomized, placebo-controlled, parallel-group, double-blind study receive the study drug (Adlea™) for pain control after TKA (total knee joint replacement).

Postoperative pain control in these patients is critical for optimal recovery of knee function. Currently, many TKA patients require opioids for up to and beyond 14 days after surgery to manage their pain; and they often experience associated side effects such as respiratory depression, confusion, dizziness, constipation, and nausea. This study evaluates the effectiveness, safety, and patient satisfaction of a single 15-mg dose of Adlea™ as an alternative to opioid treatment.

Adlea™ is a non-opioid therapeutic agent that is administered intraoperatively. It is made from purified, natural capsaicin, the primary agent in hot peppers. Capsaicin “excites” nerves that communicate pain, causing an initial burning, stinging pain that the anesthetized patient does not experience. This initial pain peaks and subsides as the nerves become overstimulated and then desensitized, resulting in prolonged pain relief.

Study participants are recruited from among patients undergoing unilateral TKA at Oregon Health & Science University. Pregnant patients are excluded. Physiological assessments are performed prior to, during, and after surgery. A sterile liquid form of the study drug is administered into the knee before the wound is closed. Pharmacokinetics is evaluated 6 or 8 hours later, and ECG is performed at 1, 24, and 48 hours after drug administration. Pain levels are recorded daily through postoperative day 42, and knee function is assessed frequently throughout the study period. Any unexpected and adverse events will be recorded and carefully followed.

 This clinical trial is sponsored by Anesiva, Inc.