A Randomized, Placebo-controlled, Double-blind Trial of Suzetrigine in Total Hip Arthroplasty

What this Trial Is About

Hip and knee joint replacements are common and painful surgeries that often require strong pain relief to help patients recover and move early. Although multiple pain control methods are used, many patients still depend on opioids, which can cause side effects like sedation, nausea, constipation, and long-term dependence. Researchers are evaluating Suzetrigine, a new non-opioid pain medication, in patients undergoing primary total hip replacement to see if it can reduce opioid use and improve recovery. This study is a phase III randomized, placebo-controlled, double-blind trial designed to assess Suzetrigine's potential benefits in this setting. Participants will be randomly assigned to receive either Suzetrigine or a placebo for seven days. The treatment starts with a loading dose given before surgery, followed by doses every 12 hours. Suzetrigine works by selectively blocking certain sodium channels involved in pain signaling, without affecting brain function. Both groups will receive standard care including neuraxial anesthesia and other pain management methods. Rescue medications like acetaminophen and ibuprofen are allowed. The study aims to explore the opioid-sparing effects and safety of Suzetrigine when added to existing multimodal pain protocols. During the study, participants will be closely monitored for pain levels using a Numeric Rating Scale at various time points from post-anesthesia care unit (PACU) entry up to 12 weeks after surgery. Researchers will measure total opioid consumption over the first 48 hours and up to seven days after surgery. Additional assessments include patient satisfaction, functional recovery scores, and incidence of side effects or adverse events. The total participation period includes treatment and follow-up visits to evaluate both short-term and longer-term outcomes related to pain and opioid use.

Suzetrigine in Total Hip Arthroplasty