Mepivacaine vs. Bupivacaine Spinal Anesthetic in Total Knee Arthroplasty
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|ClinicalTrials.gov Identifier: NCT02980926|
Recruitment Status : Completed
First Posted : December 2, 2016
Last Update Posted : March 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia, Spinal Arthroplasty, Replacement, Knee Pain Management Early Ambulation Ambulatory Surgical Procedures||Drug: Mepivacaine Drug: Bupivacaine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Experimental: Mepivacaine Spinal Anesthetic
Mepivacaine 3 mL intrathecal injection of 2% solution
This is a shorter acting spinal anesthetic as compared to the current standard of care at this institution.
Active Comparator: Bupivacaine Spinal Anesthetic
Bupivacaine 12 mg of 8.25% solution
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.
- 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.
- Pain [ Time Frame: Entire hospital admission. No data will be recorded after 96 hours. ]visual analog scale from 0 - 10
- Pain [ Time Frame: Hospital admission, maximum of 96 hours. ]morphine equivalent consumption
- 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.
- 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.
- Length of stay [ Time Frame: Hospital admission maximum of 96 hours. ]Length of stay
- Time to discharge readiness. [ Time Frame: Hospital admission maximum of 96 hours. ]Time from admission to discharge readiness as assessed by physical therapy.
- 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.
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
|United States, Michigan|
|Henry Ford West Bloomfield|
|West Bloomfield Township, Michigan, United States, 48322|
|Principal Investigator:||Jason Davis, MD||Surgeon|