Mepivacaine Versus Low-Dose Bupivacaine For Primary Total Hip and Knee Arthroplasty
Status: | Recruiting |
---|---|
Conditions: | Arthritis, Arthritis, Osteoarthritis (OA) |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | Any |
Updated: | 2/22/2019 |
Start Date: | February 18, 2019 |
End Date: | July 1, 2021 |
Contact: | Jessica L Stutzman |
Email: | stutzman.jessica@mayo.edu |
Phone: | 507-255-3602 |
Double Blind Randomized Clinical Trial Comparing Time To Return of Lower Extremity Motor Function Following Spinal Anesthetic With Mepivacaine Versus Low-Dose Bupivacaine For Primary Total Hip and Knee Arthroplasty
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 it takes for subjects to regain mobility after surgery.
anesthetics (Mepivacaine vs. Bupivacaine) as it relates to reducing post-operative
complications and the time it takes for subjects to regain mobility after surgery.
Inclusion Criteria:
- 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 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-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
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: Matthew P Abdel, M.D.
Phone: 507-284-2884
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