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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

Información sobre este estudio

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).

 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Matthew Abdel, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20450258

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