Phase
Condition
Knee Replacement
Treatment
Intra-articular Posteromedial Surgeon Administered (IPSA) Block of EXPAREL
Local Infiltration Analgesia (LIA) of EXPAREL
Adductor Canal Block (ACB) and Local Local Infiltration Analgesia of EXPAREL
Clinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for participation:
- Subjects ages 18 or older at screening 2. Indicated to undergo primary unilateral total knee arthroplasty under spinal anesthesia 3. Primary indication for TKA is degenerative osteoarthritis of the knee 4. American Society of Anesthesiologists (ASA) physical status 1, 2, or 3 (see Appendix 6) 5. Able to provide informed consent, adhere to the study schedule, and complete all study assessments 6. Body Mass Index (BMI) ≥18 and <40 kg/m2
Exclusion
Exclusion Criteria:
- Subjects who meet any of the following exclusion criteria will not be eligible forparticipation in this study:
Allergy, hypersensitivity, intolerance, or contraindication to any of the studymedications for which an alternative is not named in the protocol (e.g.,amide-type local anesthetics, opioids, bupivacaine HCl, NSAIDs)
Planned concurrent surgical procedure (e.g., bilateral TKA)
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 dosingperiod for pain that is not strictly related to the knee surgery and which, inthe Investigator's opinion, may confound the post dosing assessments
Inadequate sensory function below the knee as assessed by the Investigator
History of contralateral TKA within 1 year
Previous open knee surgery on the knee being considered for TKA. Priorarthroscopy is permitted
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 eliminationhalf-lives of such investigational drug, whichever is longer, prior to studydrug administration, or planned administration of another investigationalproduct 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 theopinion of the Investigator, could interfere with study assessments orcompliance
Currently pregnant, nursing, or planning to become pregnant during the study
Clinically significant medical disease that, in the opinion of theInvestigator, would make participation in a clinical study inappropriate. Thisincludes diabetic neuropathy, coagulation or bleeding disorders, severeperipheral vascular disease, renal insufficiency, hepatic dysfunction or otherconditions that would constitute a contraindication to participation in thestudy.
Any use of marijuana [including Tetrahydrocannabinol (THC) and Cannabidiol (CBD)] within 30 days prior to randomization, or planned use during the courseof the study
Chronic opioid use (average ≥30 oral morphine equivalents/day) within 30 daysprior to surgery
Study Design
Study Description
Connect with a study center
Cleveland Clinic Lutheran Hospital
Cleveland, Ohio 44113
United StatesSite Not Available
Cleveland Clinic Lutheran Hospital
Cleveland 5150529, Ohio 5165418 44113
United StatesActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.