Mepivacaine Versus Bupivacaine Spinal Anesthesia for Same Day Discharge Following Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Same day discharge rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Investigators and participants will not know which anesthetic agent they receive. Anesthesia providers will be aware in order to provide correct randomization.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Mepivacaine
Standard dose of mepivacaine anesthesia (1.5% or 2%) for total knee arthroplasty procedure
干预措施: Mepivacaine (Drug)
Bupivacaine
Standard dose of hyperbaric bupivacaine anesthesia (0.75%) for total knee arthroplasty procedure
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Same day discharge rate
时间窗: 24 hours
Whether a patient is discharged the same day their surgery occurred, or if they were required to stay overnight following surgery.
次要结局
- Pain Medications as evaluated by medical morphine equivalents(24 hours)
- Post-operative nausea and vomiting as assessed by clinical documentation of nausea and vomiting post-operatively(24 hours)
- Patient satisfaction levels as assessed by a 5-item Likert response scale(3 days)
- Post-operative pain score as assessed by numeric rating scale (NRS)(3 days)
- Return of sensory and motor function as assessed by ability of patient to plantar and dorsiflex lower extremity(24 hours)
- Urinary retention as assessed by time at which patient can voluntarily void bladder post-operatively(24 hours)