Mepivacaine vs. Bupivacaine Spinal Anesthetic in Total Knee Arthroplasty

Pain Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02980926
• Other study ID #: #10455
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2016
• Last updated: March 23, 2017
• Start date: December 2016
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ambulatory Surgical Procedures
• Anesthesia, Spinal
• Arthroplasty, Replacement, Knee
• Early Ambulation
• Pain Management

Intervention

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

Locations

Country	Name	City	State
United States	Henry Ford West Bloomfield	West Bloomfield Township	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain	visual analog scale from 0 - 10	Entire hospital admission. No data will be recorded after 96 hours.
Secondary	Pain	morphine equivalent consumption	Hospital admission, maximum of 96 hours.
Secondary	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.
Secondary	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.
Secondary	Length of stay	Length of stay	Hospital admission maximum of 96 hours.
Secondary	Time to discharge readiness.	Time from admission to discharge readiness as assessed by physical therapy.	Hospital admission maximum of 96 hours.
Secondary	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