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Local Anesthetic

Mepivacaine vs Bupivacaine for Knee Replacement Surgery

Phase 4
Recruiting
Research Sponsored by Prisma Health-Upstate
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial is comparing two types of spinal anesthesia for patients undergoing knee replacement surgery to see if they are ready to go home on the same day as their surgery. Data will be collected during the hospital stay

Who is the study for?
This trial is for adults scheduled for knee replacement surgery who are healthy enough to be discharged on the same day. Participants must not have conditions that would interfere with spinal anesthesia or recovery, such as allergies to local anesthetics, bleeding disorders, infection at the injection site, or severe heart or neurological issues.
What is being tested?
The study compares two types of spinal anesthesia drugs: Mepivacaine and Bupivacaine. It's designed to see which one allows patients to be ready for discharge sooner after knee replacement surgery. Patients will be randomly assigned a drug without knowing which one they receive (double-blind).
What are the potential side effects?
Possible side effects from both Mepivacaine and Bupivacaine include low blood pressure, headache, backache, nausea or vomiting. Rarely there might be nerve damage leading to weakness or numbness in lower limbs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Same day discharge rate
Secondary study objectives
Pain Medications as evaluated by medical morphine equivalents
Patient satisfaction levels as assessed by a 5-item Likert response scale
Post-operative nausea and vomiting as assessed by clinical documentation of nausea and vomiting post-operatively
+3 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Group I: BupivacaineActive Control1 Intervention
Standard dose of hyperbaric bupivacaine anesthesia (0.75%) for total knee arthroplasty procedure
Group II: MepivacaineActive Control1 Intervention
Standard dose of mepivacaine anesthesia (1.5% or 2%) for total knee arthroplasty procedure

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Who is running the clinical trial?

Prisma Health-UpstateLead Sponsor
86 Previous Clinical Trials
43,688 Total Patients Enrolled
~69 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
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