Mepivacaine Vs. Bupivacaine Spinal for TKA

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

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-13

Study Completion Date

2024-08-25

Brief Summary

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This study will enroll patients 18-75 years of age who are undergoing elective primary total knee replacement. The patients will be randomized to receive one of two spinal blocks: 1) mepivacaine or 2) bupivacaine. The primary goal is to determine which group arrives at recovery of motor function first. Ultimately, this study will explore if mepivacaine leads to earlier return of motor function and ultimately earlier movement and discharge times following total knee replacement.

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Detailed Description

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Conditions

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Total Knee Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Subject, surgeon, and care team members will be blinded to the assigned randomization group. The anesthesiologist will not be blinded.

Study Groups

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Mepivacaine Spinal

Mepivacaine (60 mg: 3ml of 2%) or will be injected into the intrathecal space.

Group Type ACTIVE_COMPARATOR

Mepivacaine Spinal

Intervention Type OTHER

spinal block using 60mg of mepivacaine

Bupivacaine Spinal

Isobaric bupivacaine (10mg: 2ml or 0.5%) will be injected into the intrathecal space.

Group Type ACTIVE_COMPARATOR

Bupivacaine Spinal

Intervention Type OTHER

spinal block using 10mg of bupivacaine

Interventions

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Mepivacaine Spinal

spinal block using 60mg of mepivacaine

Intervention Type OTHER

Bupivacaine Spinal

spinal block using 10mg of bupivacaine

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Ages 18-75 years of age
* Undergoing elective primary total knee arthroplasty

Exclusion Criteria

* Inability to ambulate or impaired motor function in lower extremities prior to surgery
* Contraindication to spinal anesthetic
* Taking over 30mg oxycodone per day (or calculated MME equivalent)
* Subjects that are unable or choose not to give informed consent
* Known preoperative substance abuse
* Pregnant women
* Allergy to all opioids

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No