Phase 3, Sciatic Nerve Block With EXPAREL for Subjects Undergoing Bunionectomy (NCT05157841) | Clinical Trial Compass
CompletedPhase 3
Phase 3, Sciatic Nerve Block With EXPAREL for Subjects Undergoing Bunionectomy
United States185 participantsStarted 2022-02-15
Plain-language summary
The study is conducted sequentially in two parts.
Part A: The purpose is to obtain information on pharmacokinetic (PK) profile, pharmacodynamics (PD), efficacy, safety, and to assess the performance of 266 mg EXPAREL vs 133 mg EXPAREL.
Part B: The purpose is to evaluate the efficacy and safety of the preferred dosage of EXPAREL from Part A compared with bupivacaine HCl.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female, ages 18 or older at screening
✓. 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
✓. Primary surgical indication is related to a bunion deformity (i.e., hallux valgus) and subject is scheduled to undergo a distal metaphyseal osteotomy procedure (e.g., Austin procedure as opposed to Lapiplasty, Lapidus bunionectomies or base wedge bunionectomies)
✓. Indicated to undergo elective (i.e., not emergency) bunionectomy
✓. 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)
✕. 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 foot surgery and which, in the Investigator's opinion, may confound the post dosing assessments
✕. Inadequate sensory function of the foot/ankle as assessed by the Investigator
✕. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
✕. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
✕. Previous participation in an EXPAREL study
✕. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance
✕. Currently pregnant, nursing, or planning to become pregnant during the study