Mepivacaine vs Bupivacaine Spinal Anesthesia for TKA

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06291727
• Other study ID #: Prisma Upstate
• Status: Recruiting
• Phase: Phase 4
• Start date: February 16, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: July 2023
• Source: Prisma Health-Upstate
• Contact: Kyle J Adams, MS
• Phone: 864-455-3449
• Email: kyle.adams[@]prismahealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Spinal
• Arthroplasty, Replacement, Knee

Intervention

Drug:
• Mepivacaine
Patients will be administered a standard dose of mepivacaine 1.5% (4.5ml, 67.5mg) for total knee arthroplasty prior to surgery
• Bupivacaine
Patients will be administered a standard dose of 0.75% hyperbaric bupivacaine (1.4ml, 10.5mg) for total knee arthroplasty prior to surgery

Locations

Country	Name	City	State
United States	Prisma Health Patewood Hospital	Greenville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Prisma Health-Upstate

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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