Mepivacaine vs Bupivacaine Spinal Anesthesia for TKA

Phase 4

Recruiting

• Conditions: Anesthesia, Spinal; Arthroplasty, Replacement, Knee

• Registration Number: NCT06291727
• Lead Sponsor: Prisma Health-Upstate

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-2-16
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Patient is at least 18 years of age who are scheduled for a primary elective TKA.<br><br> - Patient can ambulate at least 10 feet independently without human assistance.<br><br> - Patient must be a candidate for same day discharge as determined by American Society<br> of Anesthesiologists (ASA) Physical Status Classification I and II<br><br>Exclusion Criteria:<br><br> - Patients scheduled for bilateral TKAs<br><br> - Contraindication to spinal anesthesia<br><br> - Revision TKAs<br><br> - Allergy or contraindication to NSAIDs (e.g. chronic anti-coagulant use)<br><br> - Workers' Compensation patient<br><br> - Type I Diabetes<br><br> - Type II Diabetes requiring insulin medication.<br><br> - Pre-operative narcotics use with the exception of tramadol.<br><br> - Renal insufficiency (GFR < 60) that may impact post-operative protocol<br><br> - Cognitive deficiencies that prevent the patient from providing their own informed<br> consent<br><br> - Language barrier preventing completion of study forms in English

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Same day discharge rate

Secondary Outcome Measures

Name	Time	Method
Post-operative pain score as assessed by numeric rating scale (NRS);Urinary retention as assessed by time at which patient can voluntarily void bladder post-operatively;Return of sensory and motor function as assessed by ability of patient to plantar and dorsiflex lower extremity;Post-operative nausea and vomiting as assessed by clinical documentation of nausea and vomiting post-operatively;Pain Medications as evaluated by medical morphine equivalents;Patient satisfaction levels as assessed by a 5-item Likert response scale