Mepivacaine vs. Bupivacaine Spinal Anesthetic in Total Knee Arthroplasty, a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Return of motor and sensory function
研究概览
简要总结
The purpose of this study is to determine if a shorter-acting spinal anesthetic called mepivacaine has advantages over a longer-acting medication called bupivacaine.
详细描述
Different medications last for different amounts of time and can be changed depending on the length of the procedure. A short acting spinal is generally used for procedures lasting less than 90 minutes. A longer acting medication would be any that lasts longer than 90 minutes. These medications not only block the signals that travel along the pain nerves, they also prevent the signals that tell the patients muscles to move. This means that after a total knee replacement a patient may delayed in their ability to get up and start walking early after surgery. Walking early in the recovery has been shown to decrease the rate of pulmonary embolism and death. Ambulating early is also important to prevent loss of strength, constipation, pneumonia and urinary retention.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients undergoing primary total knee arthroplasty
排除标准
- •Chronic opioid users
- •Unable to give informed consent
- •Forego the use of a foley catheter
- •Those with hypersensitively to amide local anesthetics or opioids
- •Those with contraindications to spinal anesthesia
- •Conversion to general anesthesia will be excluded.
研究组 & 干预措施
Mepivacaine Spinal Anesthetic
Mepivacaine 3 mL intrathecal injection of 2% solution
干预措施: Mepivacaine (Drug)
Bupivacaine Spinal Anesthetic
Bupivacaine 12 mg of 8.25% solution
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Return of motor and sensory function
时间窗: Exams will take place in 15 minute intervals beginning with arrival to the PACU and will be continued for a maximum of 6 hours or until the exam returns to baseline for 2 consecutive exams.
Times will be recorded in minutes from the administration of the spinal anesthetic. Normal exam will include intact sensation to light touch of the thigh, calf, foot and toes. Normal motor is defined as ability to perform a straight leg raise, active knee flexion, as well as wiggling of the ankle and toes.
次要结局
- Urinary retention(Entire hospital stay beginning immediately in the post operative period until discharge to a maximum of 96 hours.)
- Length of stay(Hospital admission maximum of 96 hours.)
- Time to discharge readiness.(Hospital admission maximum of 96 hours.)
- Transient Neurologic Symptoms(Hospital admission and first follow up visit. Data will not be recorded after 3 weeks from time of spinal)
- Pain(Hospital admission, maximum of 96 hours.)
- Time to urination(24 hours maximum from time of spinal.)
研究者
M. Chad Mahan, M.D.
PGY-3
Henry Ford Health System