Mepivacaine vs. Bupivacaine Spinal for TKA

Total Knee Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05765682
• Other study ID #: Pro00125382
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2023
• Est. completion date: August 15, 2025

Study information

• Verified date: May 2024
• Source: Medical University of South Carolina
• Contact: Haley Nitchie, MHA
• Phone: 843-792-1869
• Email: nitchie[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: August 15, 2025
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

Other:
• Mepivacaine Spinal
spinal block using 60mg of mepivacaine
• Bupivacaine Spinal
spinal block using 10mg of bupivacaine

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Preoperative opioid use	Use of opioids in the pre-operative period converted to MME (morphine equivalent)	within past 90 days at time of procedure
Other	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
Other	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
Other	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
Primary	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	Ambulation	Time to first ambulation and distance at first ambulation	from anesthesia stop time until 7 days post-op
Secondary	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
Secondary	Side Effects	Side effects such as Urinary retention, dizziness, symptomatic hypotension, transient neurologic symptoms	0-48 hours post spinal placement
Secondary	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