Status:
COMPLETED
Mepivacaine Versus Low-Dose Bupivacaine For Primary Total Hip and Knee Arthroplasty
Lead Sponsor:
Mayo Clinic
Conditions:
Knee Osteoarthritis
Hip Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This research is being done to see if there is a difference between two different spinal anesthetics (Mepivacaine vs. Bupivacaine) as it relates to reducing post-operative complications and the time i...
Eligibility Criteria
Inclusion
- American Society of Anesthesiologists (ASA) physiological status I-III (patient must meet 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
- 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-steroidal anti-inflammatory drugs (i.e. celecoxib and ketorolac), and local anesthetics (defined as 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 suspected based on history.
- Severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis 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 ASRA guidelines, Clopidogrel (Plavix) held for at least 7 days, Dabigatran (Pradexa) held for 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 a previous history of menopause, hysterectomy, or tubal ligation will not be required to perform a pregnancy test. Female patients that do not meet this criterion will be asked to submit a urine sample, and will require a negative urine sample in order to proceed with study protocol. Urine sample be collected pre-procedurally.
- Impaired cognition
Key Trial Info
Start Date :
February 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2019
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT03838874
Start Date
February 25 2019
End Date
October 29 2019
Last Update
August 12 2021
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905