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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Knee Osteoarthritis, Hip Osteoarthritis

Intervention / Treatment
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* Drug: Low-Dose Bupivacaine
* Drug: Mepivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low-Dose Bupivacaine<br>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. | Drug: Low-Dose Bupivacaine<br>* 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic<br>|
| Active Comparator: Mepivacaine<br>Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA. | Drug: Mepivacaine<br>* 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Return of Lower Extremity Motor Function | 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. | Post surgery, approximately 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-Anesthesia Care Unit (PACU) Length of Stay | Number of minutes subjects were admitted to PACU following the surgical procedure | Time of discharge, approximately 1-2 days | 
| Hospital Length of Stay | Number days subjects were admitted to the hospital following the surgical procedure | Time of discharge, approximately 1-2 days | 
| Maximum Pain Score | Measured on a scale from 1 to 10 in the first 24 hours following the surgical procedure, 1=mild pain; 10=worst pain. | 24 hours following the surgical procedure | 
| Median Pain Score | Measured on a scale from 1 to 10 in the first 24 hours following the surgical procedure, 1=mild pain; 10=worst pain. | 24 hours following the surgical procedure | 
| Discharge Pain Score | Measured on a scale from 1 to 10 at time of hospital discharge, 1=mild pain; 10=worst pain. | Time of discharge, approximately 1-2 days | 
| Orthostatic Hypotension | Number of participants to experience orthostatic hypotension following the surgical procedure. | Time of discharge, approximately 1-2 days | 
| Urinary Retention | Number of participants to experience urinary retention follow the surgical procedure. | Time of discharge, approximately 1-2 days | 
| Transient Neurologic Symptoms | Number of participants to report transient neurologic symptoms | One week post-operative |