Mepivacaine vs. Bupivacaine Spinal Anesthetic in Total Knee Arthroplasty

NCT ID: NCT02980926

Last Updated: 2017-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mepivacaine Spinal Anesthetic

Mepivacaine 3 mL intrathecal injection of 2% solution

Group Type EXPERIMENTAL

Mepivacaine

Intervention Type DRUG

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

Bupivacaine Spinal Anesthetic

Bupivacaine 12 mg of 8.25% solution

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

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.

Interventions

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Mepivacaine

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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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CAS Number: 96-88-8 Carbocaine Sensorcaine Marcaine CAS 38396-39-3

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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M. Chad Mahan, M.D.

PGY-3

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jason Davis, MD

Role: PRINCIPAL_INVESTIGATOR

Surgeon

Locations

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Henry Ford West Bloomfield

West Bloomfield, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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#10455

Identifier Type: -

Identifier Source: org_study_id

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