Mepivacaine vs. Bupivacaine Spinal Anesthetic in Total Knee Arthroplasty

Phase 4

Completed

• Conditions: Anesthesia, Spinal; Arthroplasty, Replacement, Knee; Pain Management; Early Ambulation; Ambulatory Surgical Procedures
• Interventions: Drug: Mepivacaine; Drug: Bupivacaine

• Registration Number: NCT02980926
• Lead Sponsor: Henry Ford Health System

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.

Study Timeline

• Study First Submitted: 2016-09-21
• Study Start: 2016-12
• Study First Submitted QC: 2016-12-01
• Study First Posted: 2016-12-02
• Status Verified: 2017-03
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Last Update Submitted: 2017-03-23
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Adult patients undergoing primary total knee arthroplasty

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mepivacaine Spinal Anesthetic	Mepivacaine	Mepivacaine 3 mL intrathecal injection of 2% solution
Bupivacaine Spinal Anesthetic	Bupivacaine	Bupivacaine 12 mg of 8.25% solution

Primary Outcome Measures

Name	Time	Method
Return of motor and sensory function	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.	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.

Secondary Outcome Measures

Name	Time	Method
Urinary retention	Entire hospital stay beginning immediately in the post operative period until discharge to a maximum of 96 hours.	The number of straight catheterization and foley placements will be recorded as well.
Length of stay	Hospital admission maximum of 96 hours.	Length of stay
Time to discharge readiness.	Hospital admission maximum of 96 hours.	Time from admission to discharge readiness as assessed by physical therapy.
Transient Neurologic Symptoms	Hospital admission and first follow up visit. Data will not be recorded after 3 weeks from time of spinal	Any episodes of transient radiating pain in the buttocks and thigh will be recorded in the hospital charts during routine post operative rounds. This is also be discussed at the first follow up visit scheduled 2 weeks after surgery.
Pain	Hospital admission, maximum of 96 hours.	morphine equivalent consumption
Time to urination	24 hours maximum from time of spinal.	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.

Trial Locations

Locations (1)

Henry Ford West Bloomfield; 🇺🇸 West Bloomfield Township, Michigan, United States