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

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 18-008635
    NCT ID: NCT03838874
    Sponsor Protocol Number: 18-008635

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Matthew Abdel, M.D.

Open for enrollment

Contact information:

Jessica Stutzman

(507)266-1227

Stutzman.Jessica@mayo.edu

.
CLS-20450258

Mayo Clinic Footer