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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03838874
• Other study ID #: 18-008635
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 25, 2019
• Est. completion date: October 29, 2019

Study information

• Verified date: July 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: October 29, 2019
• Est. primary completion date: October 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

Drug:
• Low-Dose Bupivacaine
10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic
• Mepivacaine
70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Hospital Length of Stay	Number days subjects were admitted to the hospital following the surgical procedure	Time of discharge, approximately 1-2 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Orthostatic Hypotension	Number of participants to experience orthostatic hypotension following the surgical procedure.	Time of discharge, approximately 1-2 days
Secondary	Urinary Retention	Number of participants to experience urinary retention follow the surgical procedure.	Time of discharge, approximately 1-2 days
Secondary	Transient Neurologic Symptoms	Number of participants to report transient neurologic symptoms	One week post-operative

External Links

•   Mayo Clinic Clinical Trials