Mepivacaine vs Bupivacaine Spinal Anesthesia for TKA

Mepivacaine Versus Bupivacaine Spinal Anesthesia for Same Day Discharge Following Total Knee Arthroplasty

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.

Study Overview

• Status: Recruiting
• Conditions: Arthroplasty, Replacement, Knee; Anesthesia, Spinal
• Intervention / Treatment: Drug: Mepivacaine; Drug: Bupivacaine

Detailed Description

The purpose of this study is to evaluate the two different spinal anesthesia agents, mepivacaine and bupivacaine, and determine whether there are significant differences in their effects on readiness for same day discharge following a total knee arthroplasty.

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 via telephone or RedCap at Day 3 post-op to assess for any complications, current level of pain, and pain medication utilization.

In this double-blind (patients and assessors) study, the patients will be randomly assigned 1:1 to receive one of the following: mepivacaine 1.5% (4.5ml, 67.5mg) or 2% (3.4ml, 67.5mg), (depending on availability from pharmacy) or hyperbaric bupivacaine 0.75% (1.4ml, 10.5mg) from the spinal kit. Randomization will be computer-generated in RedCap. These doses are the currently the standard doses used for our total knee arthroplasty patients. Patients with a height of 74 inches or greater or with body mass index of 35kg/m2 or greater will be given an extra 0.5ml of local anesthetic. The intraoperative anesthesia team will not be blinded to the group assignment, but patients, surgeons, and assessors are blinded. All patients will receive the standard preoperative multimodal analgesia, consisting of celecoxib 400mg po and acetaminophen 1gm po. Research staff will unblind the study investigators immediately if requested for any potential safety concerns.

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kyle J Adams, MS; Phone Number: 864-455-3449; Email: kyle.adams@prismahealth.org

Study Locations

• United States
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Recruiting
      • Prisma Health Patewood Hospital
      • Contact: Kyle Adams; Phone Number: 864-455-3449; Email: Kyle.Adams@prismahealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mepivacaine; Standard dose of mepivacaine anesthesia (1.5% or 2%) for total knee arthroplasty procedure	Drug: Mepivacaine; Patients will be administered a standard dose of mepivacaine 1.5% (4.5ml, 67.5mg) for total knee arthroplasty prior to surgery
Active Comparator: Bupivacaine; Standard dose of hyperbaric bupivacaine anesthesia (0.75%) for total knee arthroplasty procedure	Drug: Bupivacaine; Patients will be administered a standard dose of 0.75% hyperbaric bupivacaine (1.4ml, 10.5mg) for total knee arthroplasty prior to surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Same day discharge rate	Whether a patient is discharged the same day their surgery occurred, or if they were required to stay overnight following surgery.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain score as assessed by numeric rating scale (NRS)	The NRS is a verbal pain scale that is evaluated on a scale of 0-10, with zero being no pain and 10 being 'the worst pain imaginable'. NRS pain scores will be collected while in the post-anesthesia care unit (PACU), at each physical therapy visit until discharge, and at 3 days post-operatively.	3 days
Urinary retention as assessed by time at which patient can voluntarily void bladder post-operatively	Urinary retention will be evaluated based on whether patient is able to voluntarily void their bladder post-operatively. Time at which patient is able to voluntarily void their bladder will be recorded.	24 hours
Return of sensory and motor function as assessed by ability of patient to plantar and dorsiflex lower extremity	Time until return to sensory and motor function will be evaluated based on whether patient is able to plantar or dorsiflex lower extremity after surgery. Motor and sensory function will be considered 'intact' if patient is able perform these motions after surgery. Motor function will be evaluated in the post-anesthesia care unit (PACU) and during hospital stay over the course of 24 hours post-operatively.	24 hours
Post-operative nausea and vomiting as assessed by clinical documentation of nausea and vomiting post-operatively	Nausea and vomiting will be evaluated based on the presence of clinical documentation of episodes of nausea and vomiting during hospital admission over the course of 24 hours.	24 hours
Pain Medications as evaluated by medical morphine equivalents	Post-operative medications will be documented by medical morphine equivalents of medications administered during hospital stay. Total medical morphine equivalents over the course of 24 hours post-operatively will be used to capture pain medication usage during admission.	24 hours
Patient satisfaction levels as assessed by a 5-item Likert response scale	Patient satisfaction levels will be captured using a 5-item Likert response scale with options of: 'very unsatisfied', 'unsatisfied', 'neutral', 'satisfied', and 'very satisfied' with respect to the type of anesthesia they received during their surgery. Satisfaction will be evaluated at Day 3 post-operative follow-up call.	3 days

Collaborators and Investigators

• Sponsor: Prisma Health-Upstate

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: February 16, 2024
• First Submitted That Met QC Criteria: February 26, 2024
• First Posted (Estimated): March 4, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: spinal anesthesia; bupivacaine; knee arthroplasty; mepivacaine; same day discharge
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine; Mepivacaine
• Other Study ID Numbers: Prisma Upstate

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No