Mepivacaine vs. Bupivacaine Spinal for TKA

Mepivacaine vs. Bupivacaine Spinal: Effect on Return of Motor Function, Time to Ambulation, and Length of Stay in Total Knee Arthroplasty

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.

Study Overview

• Status: Recruiting
• Conditions: Total Knee Replacement
• Intervention / Treatment: Other: Mepivacaine Spinal; Other: Bupivacaine Spinal

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haley Nitchie, MHA; Phone Number: 843-792-1869; Email: nitchie@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Contact: Haley Nitchie, MHA; Phone Number: 843-792-1869; Email: nitchie@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mepivacaine Spinal; Mepivacaine (60 mg: 3ml of 2%) or will be injected into the intrathecal space.	Other: Mepivacaine Spinal; spinal block using 60mg of mepivacaine
Active Comparator: Bupivacaine Spinal; Isobaric bupivacaine (10mg: 2ml or 0.5%) will be injected into the intrathecal space.	Other: Bupivacaine Spinal; spinal block using 10mg of bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time until return of motor function following spinal placement	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.	From anesthesia stop time until 7 days post-op

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative opioid use	Use of opioids in the pre-operative period converted to MME (morphine equivalent)	within past 90 days at time of procedure
Tourniquet use	Whether or not a tourniquet is used during surgery will be recorded as yes or no.	during procedure for up to 7 days hours after procedure ends
Cement use	Whether or not a cement is used during surgery will be recorded as yes or no.	during procedure or up to 7 days hours after procedure ends
Robotic or not	Whether or not the procedure is robotic or not will be recorded as yes or no.	during procedure or up to 7 days hours after procedure ends

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Clinton Pillow, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Estimated): August 15, 2024
• Study Completion (Estimated): August 15, 2025

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: May 1, 2024

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: Pro00125382

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No