Mepivacaine vs. Bupivacaine Spinal: Effect on Return of Motor Function, Time to Ambulation, and Length of Stay in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Time until return of motor function following spinal placement
研究概览
简要总结
This study will enroll patients 18-75 years of age who are undergoing elective primary total knee replacement. The patients will be randomized to receive one of two spinal blocks: 1) mepivacaine or 2) bupivacaine. The primary goal is to determine which group arrives at recovery of motor function first. Ultimately, this study will explore if mepivacaine leads to earlier return of motor function and ultimately earlier movement and discharge times following total knee replacement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
盲法说明
Subject, surgeon, and care team members will be blinded to the assigned randomization group. The anesthesiologist will not be blinded.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-75 years of age
- •Undergoing elective primary total knee arthroplasty
排除标准
- •Inability to ambulate or impaired motor function in lower extremities prior to surgery
- •Contraindication to spinal anesthetic
- •Taking over 30mg oxycodone per day (or calculated MME equivalent)
- •Subjects that are unable or choose not to give informed consent
- •Known preoperative substance abuse
- •Pregnant women
- •Allergy to all opioids
结局指标
主要结局
Time until return of motor function following spinal placement
时间窗: From anesthesia stop time until 7 days post-op
This will be defined as full strength with both 1) foot plantar and dorsiflexion and 2) hip flexion and 3) knee flexion in the non-operative extremity.
次要结局
- Ambulation(from anesthesia stop time until 7 days post-op)
- Length of Stay(Time from anesthesia end time to when discharge order is written, up to 30 days post-op)
- Side Effects(0-48 hours post spinal placement)
- Pain Scores(Pacu to 48 hours post-spinal placement)
研究者
Clinton F. Pillow
Physician
Medical University of South Carolina