Mepivacaine vs. Bupivacaine Spinal for TKA

Not Applicable

Recruiting

• Conditions: Total Knee Replacement
• Interventions: Other: Mepivacaine Spinal; Other: Bupivacaine Spinal

• Registration Number: NCT05765682
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-03-09
• Study Start: 2023-03-13
• Study First Posted: 2023-03-13
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30
• Primary Completion: 2024-08-15
• Study Completion: 2025-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mepivacaine Spinal	Mepivacaine Spinal	Mepivacaine (60 mg: 3ml of 2%) or will be injected into the intrathecal space.
Bupivacaine Spinal	Bupivacaine Spinal	Isobaric bupivacaine (10mg: 2ml or 0.5%) will be injected into the intrathecal space.

Primary Outcome Measures

Name	Time	Method
Time until return of motor function following spinal placement	From anesthesia stop time until 7 days post-op	This will be defined as full strength with both 1) foot plantar and dorsiflexion and 2) hip flexion and 3) knee flexion in the non-operative extremity.

Secondary Outcome Measures

Name	Time	Method
Ambulation	from anesthesia stop time until 7 days post-op	Time to first ambulation and distance at first ambulation
Length of Stay	Time from anesthesia end time to when discharge order is written, up to 30 days post-op	based on anesthesia end time to time discharge order written
Side Effects	0-48 hours post spinal placement	Side effects such as Urinary retention, dizziness, symptomatic hypotension, transient neurologic symptoms
Pain Scores	Pacu to 48 hours post-spinal placement	Visual Analog Pain Score 0-100 pain scores at rest, and with movement. A lower pain score means a better outcome.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States