Phase 3 Adductor Canal Block With EXPAREL in Subjects Undergoing Primary Unilateral Total Knee Ar… (NCT05139030) | Clinical Trial Compass
CompletedPhase 3
Phase 3 Adductor Canal Block With EXPAREL in Subjects Undergoing Primary Unilateral Total Knee Arthroplasty
United States167 participantsStarted 2022-01-18
Plain-language summary
The purpose of the study is to compare magnitude of postsurgical analgesic effect in different groups following a single dose of study drug when administered via adductor canal block in subjects undergoing primary unilateral total knee arthroplasty.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female, ages 18 or older at screening.
✓. Indicated to undergo primary unilateral total knee arthroplasty under spinal anesthesia.
✓. Primary indication for TKA is degenerative osteoarthritis of the knee.
✓. American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
✓. Able to provide informed consent, adhere to the study schedule, and complete all study assessments.
✓. Body Mass Index (BMI) ≥18 and \<40 kg/m2.
Exclusion criteria
✕. Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine HCl, NSAIDs).
✕. Undergoing unicompartmental TKA or revision TKA.
✕. Concurrent painful physical condition (e.g., arthritis, fibromyalgia, cancer) that may require analgesic treatment with NSAIDs or opioids in the post dosing period for pain that is not strictly related to the knee surgery and which, in the Investigator's opinion, may confound the post dosing assessments.
✕. Inadequate sensory function below the knee as assessed by the Investigator.