Mepivacaine vs Bupivacaine Spinal Anesthesia for TKA

NCT06291727 | Completed Phase 4

• 1 other identifier: Prisma Upstate
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, double-blind prospective randomized controlled trial comparing mepivacaine and bupivacaine spinal anesthesia for same-day discharge readiness following a unilateral primary elective TKA procedure. Study data will be collected during the patient's hospital stay for their TKA procedure, and the primary outcome of same-day discharge readiness will be assessed the day of surgery. Patients will also be contacted at Day 3 post-op to assess for any complications, current level of pain, and pain medication utilization.

Conditions

Anesthesia, Spinal; Arthroplasty, Replacement, Knee

Keywords

knee arthroplasty; spinal anesthesia; same day discharge; mepivacaine; bupivacaine

Outcome Measures

Primary Outcomes (1)

• Same day discharge rate

  Whether a patient is discharged the same day their surgery occurred, or if they were required to stay overnight following surgery.

  24 hours

Secondary Outcomes (6)

• Post-operative pain score as assessed by numeric rating scale (NRS)

  3 days

• Urinary retention as assessed by time at which patient can voluntarily void bladder post-operatively

  24 hours

• Return of sensory and motor function as assessed by ability of patient to plantar and dorsiflex lower extremity

  24 hours

• Post-operative nausea and vomiting as assessed by clinical documentation of nausea and vomiting post-operatively

  24 hours

• Pain Medications as evaluated by medical morphine equivalents

  24 hours

Study Arms (2)

Mepivacaine

ACTIVE COMPARATOR

Standard dose of mepivacaine anesthesia (1.5% or 2%) for total knee arthroplasty procedure

Drug: Mepivacaine

Bupivacaine

ACTIVE COMPARATOR

Standard dose of hyperbaric bupivacaine anesthesia (0.75%) for total knee arthroplasty procedure

Drug: Bupivacaine

Interventions

Mepivacaine DRUG

Patients will be administered a standard dose of mepivacaine 1.5% (4.5ml, 67.5mg) for total knee arthroplasty prior to surgery

Mepivacaine

Bupivacaine DRUG

Patients will be administered a standard dose of 0.75% hyperbaric bupivacaine (1.4ml, 10.5mg) for total knee arthroplasty prior to surgery

Bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is at least 18 years of age who are scheduled for a primary elective TKA.
• Patient can ambulate at least 10 feet independently without human assistance.
• Patient must be a candidate for same day discharge as determined by American Society of Anesthesiologists (ASA) Physical Status Classification I and II

You may not qualify if:

• Patients scheduled for bilateral TKAs
• Contraindication to spinal anesthesia
• Revision TKAs
• Allergy or contraindication to NSAIDs (e.g. chronic anti-coagulant use)
• Workers' Compensation patient
• Type I Diabetes
• Type II Diabetes requiring insulin medication.
• Pre-operative narcotics use with the exception of tramadol.
• Renal insufficiency (GFR \< 60) that may impact post-operative protocol
• Cognitive deficiencies that prevent the patient from providing their own informed consent
• Language barrier preventing completion of study forms in English

Sponsors & Collaborators

• Prisma Health-Upstate: lead

Study Sites (1)

Prisma Health Patewood Hospital

Greenville, South Carolina, 29615, United States

Location

MeSH Terms

Interventions

Mepivacaine; Bupivacaine

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Investigators and participants will not know which anesthetic agent they receive. Anesthesia providers will be aware in order to provide correct randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized 1:1 to one of two groups; one receiving Mepivacaine spinal anesthesia and the other receiving Bupivacaine spinal anesthesia for total knee arthroplasty (TKA).

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: March 4, 2024
• Study Start: February 16, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

US (1)