Clinical trial NCT03838874: Mepivacaine Versus Low-Dose Bupivacaine For Primary Total Hip and Knee Arthroplasty
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Knee Osteoarthritis
Hip Osteoarthritis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Time to Return of Lower Extremity Motor Function
timeFrame: Post surgery, approximately 1 day
Secondary outcomes:
measure: Post-Anesthesia Care Unit (PACU) Length of Stay
timeFrame: Time of discharge, approximately 1-2 days
measure: Hospital Length of Stay
timeFrame: Time of discharge, approximately 1-2 days
measure: Maximum Pain Score
timeFrame: 24 hours following the surgical procedure
measure: Median Pain Score
timeFrame: 24 hours following the surgical procedure
measure: Discharge Pain Score
timeFrame: Time of discharge, approximately 1-2 days
measure: Orthostatic Hypotension
timeFrame: Time of discharge, approximately 1-2 days
measure: Urinary Retention
timeFrame: Time of discharge, approximately 1-2 days
measure: Transient Neurologic Symptoms
timeFrame: One week post-operative
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew P Abdel, MD
role: PRINCIPAL_INVESTIGATOR
References: