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Clinical Trials/NCT02980926
NCT02980926
Completed
Phase 4

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

Henry Ford Health System1 site in 1 country32 target enrollmentDecember 2016

Overview

Phase
Phase 4
Intervention
Mepivacaine
Conditions
Anesthesia, Spinal
Sponsor
Henry Ford Health System
Enrollment
32
Locations
1
Primary Endpoint
Return of motor and sensory function
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2016
End Date
March 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

M. Chad Mahan, M.D.

PGY-3

Henry Ford Health System

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.

Arms & Interventions

Mepivacaine Spinal Anesthetic

Mepivacaine 3 mL intrathecal injection of 2% solution

Intervention: Mepivacaine

Bupivacaine Spinal Anesthetic

Bupivacaine 12 mg of 8.25% solution

Intervention: Bupivacaine

Outcomes

Primary Outcomes

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

  • Urinary retention(Entire hospital stay beginning immediately in the post operative period until discharge to a maximum of 96 hours.)
  • Length of stay(Hospital admission maximum of 96 hours.)
  • Time to discharge readiness.(Hospital admission maximum of 96 hours.)
  • Transient Neurologic Symptoms(Hospital admission and first follow up visit. Data will not be recorded after 3 weeks from time of spinal)
  • Pain(Hospital admission, maximum of 96 hours.)
  • Time to urination(24 hours maximum from time of spinal.)

Study Sites (1)

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