Mepivacaine vs. Bupivacaine Spinal Anesthetic in Total Knee Arthroplasty

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

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.

Study Overview

• Status: Completed
• Conditions: Pain Management; Arthroplasty, Replacement, Knee; Ambulatory Surgical Procedures; Anesthesia, Spinal; Early Ambulation
• Intervention / Treatment: Drug: Mepivacaine; Drug: 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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • West Bloomfield Township, Michigan, United States, 48322
      • Henry Ford West Bloomfield

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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: Carbocaine; CAS Number: 96-88-8
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: Marcaine; Sensorcaine; CAS 38396-39-3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return of motor and sensory function	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	visual analog scale from 0 - 10	Entire hospital admission. No data will be recorded after 96 hours.
Pain	morphine equivalent consumption	Hospital admission, maximum of 96 hours.
Time to urination	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.	24 hours maximum from time of spinal.
Urinary retention	The number of straight catheterization and foley placements will be recorded as well.	Entire hospital stay beginning immediately in the post operative period until discharge to a maximum of 96 hours.
Length of stay	Length of stay	Hospital admission maximum of 96 hours.
Time to discharge readiness.	Time from admission to discharge readiness as assessed by physical therapy.	Hospital admission maximum of 96 hours.
Transient Neurologic Symptoms	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.	Hospital admission and first follow up visit. Data will not be recorded after 3 weeks from time of spinal

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: Jason Davis, MD, Surgeon

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: September 21, 2016
• First Submitted That Met QC Criteria: December 1, 2016
• First Posted (Estimate): December 2, 2016

Study Record Updates

• Last Update Posted (Actual): March 27, 2017
• Last Update Submitted That Met QC Criteria: March 23, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine; Mepivacaine
• Other Study ID Numbers: #10455

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No