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Local Anesthetic

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

Study 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.Check my eligibility

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).See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Same day discharge rate

Secondary outcome measures

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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Prisma Health-UpstateLead Sponsor

83 Previous Clinical Trials

42,890 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently able to participate in this ongoing research study?

"Indeed, details on clinicaltrials.gov highlight that this investigation is presently in search of candidates. Initially shared on February 16th, 2024, the study was last revised on February 26th, 2024. A total of 138 participants are sought at a single designated site."

Answered by AI

What is the safety profile of Mepivacaine in individuals?

"For this Phase 4 investigation, the safety of Mepivacaine is rated at a level 3 by our team due to its approved status for clinical use."

Answered by AI

What is the upper limit for the number of participants involved in this research endeavor?

"Yes, information from clinicaltrials.gov shows that this study is actively seeking participants. The trial was initially uploaded on February 16th, 2024 and last modified on February 26th, 2024. A total of 138 individuals are sought across a single site for enrollment in the research."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mepivacaine vs Bupivacaine Spinal Anesthesia for TKA

2024. "Mepivacaine vs Bupivacaine Spinal Anesthesia for TKA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06291727.

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