Mepivacaine vs. Bupivacaine Spinal Anesthetic in Total Knee Arthroplasty

Henry Ford Health System32 enrolled

Overview

The purpose of this study is to determine if a shorter-acting spinal anesthetic called mepivacaine has advantages over a longer-acting medication called bupivacaine.

Different medications last for different amounts of time and can be changed depending on the length of the procedure. A short acting spinal is generally used for procedures lasting less than 90 minutes. A longer acting medication would be any that lasts longer than 90 minutes. These medications not only block the signals that travel along the pain nerves, they also prevent the signals that tell the patients muscles to move. This means that after a total knee replacement a patient may delayed in their ability to get up and start walking early after surgery. Walking early in the recovery has been shown to decrease the rate of pulmonary embolism and death. Ambulating early is also important to prevent loss of strength, constipation, pneumonia and urinary retention.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Anesthesia, Spinal Arthroplasty, Replacement, Knee Pain Management Early Ambulation Ambulatory Surgical Procedures

Interventions

MepivacaineDRUG

This is a shorter acting spinal anesthetic as compared to the current standard of care at this institution.

BupivacaineDRUG

This is the current standard of care at this institution and many centers. This is a longer acting spinal anesthetic compared to the study drug.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients undergoing primary total knee arthroplasty Exclusion Criteria: * Chronic opioid users * Unable to give informed consent * Forego the use of a foley catheter * Those with hypersensitively to amide local anesthetics or opioids * Those with contraindications to spinal anesthesia * Conversion to general anesthesia will be excluded.

Locations (1)

Henry Ford West Bloomfield

West Bloomfield, Michigan, United States

Outcomes

Primary Outcomes

Return of motor and sensory function

Times will be recorded in minutes from the administration of the spinal anesthetic. Normal exam will include intact sensation to light touch of the thigh, calf, foot and toes. Normal motor is defined as ability to perform a straight leg raise, active knee flexion, as well as wiggling of the ankle and toes.

Time frame: Exams will take place in 15 minute intervals beginning with arrival to the PACU and will be continued for a maximum of 6 hours or until the exam returns to baseline for 2 consecutive exams.

Secondary Outcomes

Pain

visual analog scale from 0 - 10

Time frame: Entire hospital admission. No data will be recorded after 96 hours.

Pain

morphine equivalent consumption

Time frame: Hospital admission, maximum of 96 hours.

Time to urination

The total time between the administration of spinal anesthesia to the first episode of spontaneous urination will be recorded. Patients who require greater than 6 hours to urinate independently are followed per hospital protocol with serial bladder scans and straight catheterization for urinary retention as needed. Patients who exceed 6 hours to urinate will be defined as having urinary retention.

Time frame: 24 hours maximum from time of spinal.

Urinary retention

The number of straight catheterization and foley placements will be recorded as well.

Time frame: Entire hospital stay beginning immediately in the post operative period until discharge to a maximum of 96 hours.

Length of stay

Time frame: Hospital admission maximum of 96 hours.

Data from ClinicalTrials.gov

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