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
Tab Title Description
Study type
ObservationalDescribes 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.
Study IDs
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. 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