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Completed

NCT Number: NCT02980926

Mepivacaine vs. Bupivacaine Spinal Anesthetic in Total Knee Arthroplasty

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.

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Key information

Conditions

Anesthesia, Spinal Agnosia Ambulatory Surgical Procedures Arthroplasty, Replacement, Knee Early Ambulation Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Henry Ford West Bloomfield

West Bloomfield, Michigan, 48322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mepivacaine

Drug

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

Other names: CAS Number: 96-88-8, Carbocaine

Bupivacaine

Drug

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.

Other names: Sensorcaine, Marcaine, CAS 38396-39-3

Primary outcomes

  1. Return of motor and sensory function

    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.

    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 outcomes

  1. Pain

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

    visual analog scale from 0 - 10

  2. Pain

    Time frame: Hospital admission, maximum of 96 hours.

    morphine equivalent consumption

  3. Time to urination

    Time frame: 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.

  4. Urinary retention

    Time frame: 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.

  5. Length of stay

    Time frame: Hospital admission maximum of 96 hours.

    Length of stay

  6. Time to discharge readiness.

    Time frame: Hospital admission maximum of 96 hours.

    Time from admission to discharge readiness as assessed by physical therapy.

  7. Transient Neurologic Symptoms

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

Mepivacaine vs. Bupivacaine Spinal Anesthetic in Total Knee Arthroplasty, a Randomized Controlled Clinical Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 2, 2016
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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