Last updated: July 20, 2021
Sponsor: Mayo Clinic
Overall Status: Completed
Phase
2/3
Condition
Knee Injuries
Osteoarthritis
Treatment
N/AClinical Study ID
NCT03838874
18-008635
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physiological status I-III (patient mustmeet criteria of a status I-III in the ASA Physical Status Classification System:I=Normal Healthy Patient, II=Mild Systemic Disease, and III=Severe Systemic Disease)
- Unilateral primary TKA or THA
- 18+ years of age
- Able to provide informed consent
Exclusion
Exclusion Criteria:
- Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome
- Chronic opioid use (>1 mos) with OME >5 mg/day OR acute opioid use (< 1 mos) with OME > 30 mg/day.
- Body mass index (BMI) > 45 kg/m2
- Severe drug allergy* to medications used in this study, including non-steroidalanti-inflammatory drugs (i.e. celecoxib and ketorolac), and local anesthetics (definedas an immune reaction resulting in shortness of breath, hives, anaphylaxis, wheezing,and fever)
- Major systemic medical comorbidities such as:
- Pre-existing severe renal disorder defined as glomerular filtration rate (GFR) <50 units/m2 (if labs are available), currently on dialysis, or highly suspectedbased on history.
- Severe hepatic disorder defined as current or past diagnosis of acute/subacutenecrosis of liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), chronic hepatitis/toxic hepatitis, liver abscess,hepatic coma, hepatorenal syndrome, other disorders of liver
- Contraindication to spinal anesthesia technique (e.g., known spinal stenosis,coagulopathy, sepsis, infection at site of injection, uncooperative, refusal,anticoagulation medications not held within appropriate time frame*). *Per ASRAguidelines, Clopidogrel (Plavix) held for at least 7 days, Dabigatran (Pradexa) heldfor at least 5 days, Rivaroxaban (Xarelto)held for at least 3 days, Warfarin (Coumadin)held for at least 5 days or recent INR of less than 1.4, Enoxaparin (Lovenox) with doses > 1 mg/kg held for close to 24 hours.
- Known to be currently pregnant or actively breastfeeding. Patients that have aprevious history of menopause, hysterectomy, or tubal ligation will not be required toperform a pregnancy test. Female patients that do not meet this criterion will beasked to submit a urine sample, and will require a negative urine sample in order toproceed with study protocol. Urine sample be collected pre-procedurally.
- Impaired cognition
Study Design
Total Participants: 154
Study Start date:
February 25, 2019
Estimated Completion Date:
October 29, 2019
Connect with a study center
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United StatesSite Not Available
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