NCT05765682

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

March 13, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.4 years

First QC Date

January 27, 2023

Last Update Submit

September 4, 2024

Conditions

Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Ambulation

    from anesthesia stop time until 7 days post-op

  • Length of Stay

    Time from anesthesia end time to when discharge order is written, up to 30 days post-op

  • Side Effects

    0-48 hours post spinal placement

  • Pain Scores

    Pacu to 48 hours post-spinal placement

Other Outcomes (4)

  • Preoperative opioid use

    within past 90 days at time of procedure

  • Tourniquet use

    during procedure for up to 7 days hours after procedure ends

  • Cement use

    during procedure or up to 7 days hours after procedure ends

  • +1 more other outcomes

Study Arms (2)

Mepivacaine Spinal

ACTIVE COMPARATOR

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

Other: Mepivacaine Spinal

Bupivacaine Spinal

ACTIVE COMPARATOR

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

Other: Bupivacaine Spinal

Interventions

Mepivacaine SpinalOTHER

spinal block using 60mg of mepivacaine

Mepivacaine Spinal
Bupivacaine SpinalOTHER

spinal block using 10mg of bupivacaine

Bupivacaine Spinal

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

  • Pillow CF, Brewbaker C, Wolf BJ, Barrett W, Hansen E, Brown A, Crawford D, Wilson SH. Mepivacaine versus bupivacaine spinal anesthesia for return of motor function following total knee arthroplasty: a randomized controlled trial. Reg Anesth Pain Med. 2025 May 1:rapm-2024-106342. doi: 10.1136/rapm-2024-106342. Online ahead of print.

    PMID: 40316299DERIVED

Study Officials

  • Clinton Pillow, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Subject, surgeon, and care team members will be blinded to the assigned randomization group. The anesthesiologist will not be blinded.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

January 27, 2023

First Posted

March 13, 2023

Study Start

March 13, 2023

Primary Completion

August 23, 2024

Study Completion

August 25, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)