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Completed

NCT Number: NCT05765682

Mepivacaine Vs. Bupivacaine Spinal for TKA

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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Key information

Conditions

Total Knee Replacement

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mepivacaine Spinal

Other

spinal block using 60mg of mepivacaine

Bupivacaine Spinal

Other

spinal block using 10mg of bupivacaine

Primary outcomes

  1. Time until return of motor function following spinal placement

    Time frame: 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 outcomes

  1. Ambulation

    Time frame: from anesthesia stop time until 7 days post-op

    Time to first ambulation and distance at first ambulation

  2. Length of Stay

    Time frame: 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

  3. Side Effects

    Time frame: 0-48 hours post spinal placement

    Side effects such as Urinary retention, dizziness, symptomatic hypotension, transient neurologic symptoms

  4. Pain Scores

    Time frame: 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.

Other outcomes

  1. Preoperative opioid use

    Time frame: within past 90 days at time of procedure

    Use of opioids in the pre-operative period converted to MME (morphine equivalent)

  2. Tourniquet use

    Time frame: during procedure for up to 7 days hours after procedure ends

    Whether or not a tourniquet is used during surgery will be recorded as yes or no.

  3. Cement use

    Time frame: during procedure or up to 7 days hours after procedure ends

    Whether or not a cement is used during surgery will be recorded as yes or no.

  4. Robotic or not

    Time frame: during procedure or up to 7 days hours after procedure ends

    Whether or not the procedure is robotic or not will be recorded as yes or no.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 13, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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