Mepivacaine vs Bupivacaine Spinal Anesthesia for TKA (NCT06291727) | Clinical Trial Compass
CompletedPhase 4
Mepivacaine vs Bupivacaine Spinal Anesthesia for TKA
United States138 participantsStarted 2024-02-16
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.