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Mepivacaine vs. Bupivacaine Spinal Anesthetic in Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02980926
Recruitment Status : Completed
First Posted : December 2, 2016
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
M. Chad Mahan, M.D., 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.

Condition or disease Intervention/treatment Phase
Anesthesia, Spinal Arthroplasty, Replacement, Knee Pain Management Early Ambulation Ambulatory Surgical Procedures Drug: Mepivacaine Drug: Bupivacaine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mepivacaine vs. Bupivacaine Spinal Anesthetic in Total Knee Arthroplasty, a Randomized Controlled Clinical Trial
Actual Study Start Date : December 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Mepivacaine Spinal Anesthetic
Mepivacaine 3 mL intrathecal injection of 2% solution
Drug: Mepivacaine
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

Active Comparator: Bupivacaine Spinal Anesthetic
Bupivacaine 12 mg of 8.25% solution
Drug: Bupivacaine
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 Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980926


Locations
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United States, Michigan
Henry Ford West Bloomfield
West Bloomfield Township, Michigan, United States, 48322
Sponsors and Collaborators
Henry Ford Health System
Investigators
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Principal Investigator: Jason Davis, MD Surgeon

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Responsible Party: M. Chad Mahan, M.D., PGY-3, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT02980926    
Other Study ID Numbers: #10455
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Bupivacaine
Mepivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents