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

Phase 2

Completed

Conditions: Knee Osteoarthritis
Hip Osteoarthritis

Interventions: Drug: Low-Dose Bupivacaine
Drug: Mepivacaine

Registration Number: NCT03838874

Lead Sponsor: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 154

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-Dose Bupivacaine	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.
Mepivacaine	Mepivacaine	Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA.

Primary Outcome Measures

Name	Time	Method
Time to Return of Lower Extremity Motor Function	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 Outcome Measures

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