A Study Evaluating Time to Return of Lower Extremity Motor Function Following Spinal Anesthetic with Mepivacaine Versus Low-Dose Bupivacaine for Primary Total Hip and Knee Arthroplasty

Overview

About this study

The purpose of this study is to evaluate time to return of lower extremity motor function following mepivacaine versys low-dose bupivacaine spinal anesthetic among patients undergoing primary total hip arthorplasty (THA) and total knee arthroplasty (TKA).

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Unilateral primary TKA or THA.
  • 18+ years of age.
  • Able to provide informed consent.

Exclusion Criteria: 

  • 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.
  • 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.
  • Lower extremity motor deficit.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Matthew Abdel, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available
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CLS-20450258

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