Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficac… (NCT03954639) | Clinical Trial Compass
WithdrawnPhase 3
Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupi vs. Bupi Only Administered as Combined Sciatic and Adductor Canal Nerve Block for Postsurgical Analgesia in Lower Extremity Surgeries
Stopped: Sponsor Decision.
0Started 2020-06-15
Plain-language summary
This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 81 subjects undergoing lower extremity surgeries with combined sciatic and adductor canal nerve block.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Healthy adult male or female volunteers ages 18 or older
✓. 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 ≥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 (eg, amide-type local anesthetics, opioids, bupivacaine, NSAIDs)
✕. Documented history of long-term diabetes, renal (serum creatinine level \>2mg/dL \[176.8 μmol/L\]) or hepatic dysfunction (serum alanine or aspartame transferase \> 3 times the upper limit of normal), coagulation or bleeding disorder and severe peripheral vascular disease
✕. Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the post dosing period for pain and which, in the investigator's opinion may confound the post dosing assessments
✕. 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
✕. 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