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Novel Extended-Release Bupivacaine Polymer for Sustained Pain Relief Following Total Knee Arthroplasty

RecruitingPhase 4Ages 18 Years - anyAllHenry Ford Health System
NCT07775248 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Participants are being invited to take part in a research study about pain control after total knee replacement surgery (also called total knee arthroplasty or TKA). The goal of this study is to see if a new long-acting medication, called Zynrelef, can control pain after surgery as well as or better than two other common pain treatments - a nerve block or a standard injection into the knee during surgery. Knee replacement is done to reduce pain and improve movement in people with severe knee arthritis. While the surgery can be very successful, pain during the first few days after surgery can make recovery harder. Many patients need strong opioid pain medicines, but these medicines can have side effects and may lead to dependence. The investigators want to find ways to control pain that reduce or even remove the need for opioids. If participants join this study, they will be randomly pl

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adult patients age 18 and older undergoing primary total knee replacement by fellowship trained Orthopedic Surgeons in Henry Ford Health System with planned outpatient same-day discharge. Exclusion Criteria: * Incomplete data in medical records * Non-English speakers * Chronic opioid use in the last 3 months * Ipsilateral joint surgery in the last year * Undergoing bilateral knee arthroplasty * Cannot tolerate oral medications * Swallowing difficulties * Intolerance to acetaminophen, anti-inflammatories, muscle relaxants, gabapentinoids, or opioids/tramadol * History of alcohol abuse * Drug abuse * Renal impairment * Peptic ulcer disease * GI bleeding * Illicit narcotic usage in the past 6 months * Chronic liver disease * Chronic pain syndromes
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What it tests

  • Periarticular Injection
  • Adductor Canal Block
  • Bupivacaine-Meloxicam
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Where

1 site
Henry Ford Medical Center - Grosse Pointe Cottage
Grosse Pointe Farms, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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