Clinical trial NCT02980926: Mepivacaine vs. Bupivacaine Spinal Anesthetic in Total Knee Arthroplasty
Official title: Mepivacaine vs. Bupivacaine Spinal Anesthetic in Total Knee Arthroplasty, a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia, Spinal
Arthroplasty, Replacement, Knee
Pain Management
Early Ambulation
Ambulatory Surgical Procedures
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2016-12-02
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Return of motor and sensory function
timeFrame: 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:
measure: Pain
timeFrame: Entire hospital admission. No data will be recorded after 96 hours.
measure: Pain
timeFrame: Hospital admission, maximum of 96 hours.
measure: Time to urination
timeFrame: 24 hours maximum from time of spinal.
measure: Urinary retention
timeFrame: Entire hospital stay beginning immediately in the post operative period until discharge to a maximum of 96 hours.
measure: Length of stay
timeFrame: Hospital admission maximum of 96 hours.
measure: Time to discharge readiness.
timeFrame: Hospital admission maximum of 96 hours.
measure: Transient Neurologic Symptoms
timeFrame: Hospital admission and first follow up visit. Data will not be recorded after 3 weeks from time of spinal
Other outcomes:
Locations:
city: West Bloomfield Township
country: United States
facility: Henry Ford West Bloomfield
state: Michigan
Study officials:
affiliation: Surgeon
name: Jason Davis, MD
role: PRINCIPAL_INVESTIGATOR
References: