Comparing mepivacaine and bupivacaine for spinal anesthesia in knee surgery
Mepivacaine Versus Bupivacaine Spinal Anesthesia for Same Day Discharge Following Total Knee Arthroplasty
PHASE4 · Prisma Health-Upstate · NCT06291727
This study is testing whether mepivacaine or bupivacaine helps people recover faster after knee surgery so they can go home the same day.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Prisma Health-Upstate (other) |
| Locations | 1 site (Greenville, South Carolina) |
| Trial ID | NCT06291727 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective, double-blind randomized controlled trial that compares the effects of two spinal anesthesia agents, mepivacaine and bupivacaine, on the readiness for same-day discharge following a unilateral primary elective total knee arthroplasty (TKA). Patients will be randomly assigned to receive either mepivacaine or bupivacaine, and their discharge readiness will be assessed on the day of surgery. Additionally, follow-up assessments will be conducted on Day 3 post-operation to evaluate complications, pain levels, and pain medication use. The study aims to determine if one anesthetic leads to better outcomes in terms of discharge readiness.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older scheduled for a primary elective total knee arthroplasty who can ambulate independently and are classified as ASA Physical Status I or II.
Not a fit: Patients who may not benefit from this study include those scheduled for bilateral TKAs, those with contraindications to spinal anesthesia, or those with significant comorbidities such as uncontrolled diabetes or renal insufficiency.
Why it matters
Potential benefit: If successful, this study could enhance patient recovery and discharge processes after knee surgery, potentially leading to improved patient satisfaction and reduced hospital stays.
How similar studies have performed: Other studies comparing different spinal anesthesia agents have shown promising results, suggesting that this approach may yield beneficial insights into anesthesia practices for knee surgeries.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Greenville, South Carolina
- Prisma Health Patewood Hospital — Greenville, South Carolina, United States (RECRUITING)
Study contacts
- Study coordinator: Kyle J Adams, MS
- Email: kyle.adams@prismahealth.org
- Phone: 864-455-3449
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anesthesia, Spinal, Arthroplasty, Replacement, Knee, knee arthroplasty, spinal anesthesia, same day discharge, mepivacaine, bupivacaine