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Mepivacaine Versus Low-Dose Bupivacaine For Primary Total Hip and Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT03838874
Recruitment Status : Not yet recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Matthew P. Abdel, M.D., Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Hip Osteoarthritis Drug: Low-Dose Bupivacaine Drug: Mepivacaine Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: Low-Dose Bupivacaine
Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA. A standardized study card will be used to track patients throughout their various phases of care.
Drug: Low-Dose Bupivacaine
10 mg

Active Comparator: Mepivacaine
Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA. A standardized study card will be used to track patients throughout their various phases of care.
Drug: Mepivacaine
70 mg




Primary Outcome Measures :
  1. Time to return of lower extremity motor function [ Time Frame: End of Study (6-9 Days post operation) ]
    To evaluate the time to return of lower extremity motor function between mepivacaine and low-dose bupivacaine spinal anesthetic among patients undergoing primary total knee arthroplasty and total hip arthroplasty. This will be assessed by measuring time from spinal anesthetic administration to postoperative achievement of Bromage 0 function (return of spontaneous ankle, knee, and hip movement) in the non-operative extremity.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03838874


Contacts
Contact: Jessica L Stutzman 507-255-3602 stutzman.jessica@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Matthew P Abdel, M.D.    507-284-2884    orcu@mayo.edu   
Contact: Jessica Stutzman    507-255-3602    Stutzman.Jessica@mayo.edu   
Principal Investigator: Matthew P Abdel, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Matthew P Abdel, MD Mayo Clinic

Responsible Party: Matthew P. Abdel, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03838874     History of Changes
Other Study ID Numbers: 18-008635
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Bupivacaine
Mepivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents