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

Mayo Clinic1 site in 1 country154 target enrollmentFebruary 25, 2019

ConditionsKnee Osteoarthritis Hip Osteoarthritis

InterventionsLow-Dose Bupivacaine Mepivacaine

DrugsLow-Dose Bupivacaine Mepivacaine

Overview

Phase: Phase 2
Intervention: Low-Dose Bupivacaine
Conditions: Knee Osteoarthritis
Sponsor: Mayo Clinic
Enrollment: 154
Locations: 1
Primary Endpoint: Time to Return of Lower Extremity Motor Function
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 25, 2019

End Date

October 29, 2019

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Matthew P. Abdel, M.D.

Principal Investigator

Mayo Clinic

Eligibility 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

Arms & Interventions

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.

Intervention: Low-Dose Bupivacaine

Mepivacaine

Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA.

Intervention: Mepivacaine

Outcomes

Primary Outcomes

Time to Return of Lower Extremity Motor Function

Time Frame: Post surgery, approximately 1 day

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 at 15-minute intervals.

Secondary Outcomes

Post-Anesthesia Care Unit (PACU) Length of Stay(Time of discharge, approximately 1-2 days)
Discharge Pain Score(Time of discharge, approximately 1-2 days)
Hospital Length of Stay(Time of discharge, approximately 1-2 days)
Maximum Pain Score(24 hours following the surgical procedure)
Median Pain Score(24 hours following the surgical procedure)
Urinary Retention(Time of discharge, approximately 1-2 days)
Transient Neurologic Symptoms(One week post-operative)
Orthostatic Hypotension(Time of discharge, approximately 1-2 days)