A Three-Arm, Double-Blinded, Randomized Controlled Trial Comparing the Efficacy of Adductor Canal Pain Catheters Following Total Knee Arthroplasty
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Post-operative Pain Levels
研究概览
简要总结
The purpose of this research is to study how well the adductor canal pain catheters works after a total knee arthroplasty or replacement of the knee joint. The catheter works by using either an intermittent bolus injection to provide a large dose of medication or continuous infusion of pain medicine, ropivacaine 0.2%, compared to a single-shot adductor canal block.
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
This will be a double-blinded study. Computer randomization will be used for patient grouping and the research pharmacy will dispense the medication to the anesthesia team, who will set the adductor catheter dosing based upon randomization. The surgical team and patient will remain blinded to the medication and dosing regimen.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 90 years.
- •Willing to participate in the study and competent to provide informed consent.
- •Willing to comply with protocol procedures.
- •Has an underlying diagnosis of osteoarthritis indicated for a total knee arthroplasty.
排除标准
- •The patient must not have taken any narcotic medications (schedule II) during the 3 months leading up to the surgery.
- •The patient must not be allergic or intolerant to a medication used in the multimodal pain pathway.
- •Revision knee arthroplasty.
- •Uncontrolled diabetes with A1C > 8.0%.
研究组 & 干预措施
Ropivacaine intermittent bolus
Subjects will have a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with 0.2% ropivacaine dispersed in pulsed intermittent bolus.
干预措施: Ropivacaine Intermittent Bolus (Drug)
Ropivacaine continuous
Subjects will have a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with 0.2% ropivacaine dispersed in a continuous infusion.
干预措施: Ropivacaine Continuous Infusion (Drug)
Single shot adductor canal
Subjects will have a catheter placed in the Post Anesthesia Care Unit following clinically indicated surgery with saline.
干预措施: Placebo (Drug)
结局指标
主要结局
Post-operative Pain Levels
时间窗: 14 days post-operatively
Patient self-reported pain intensity score measured on the Visual Analogue Scale (VAS) rated from 0-10, where 0 was no pain and 10 was the worst pain imaginable.
次要结局
- Amount of Medication Administered(60 days, or until discontinuation of narcotic medication (whichever is later))
- Duration of Narcotic Used(60 days, or until discontinuation of narcotic medication (whichever is later))
研究者
Benjamin K. Wilke
Principal Investigator
Mayo Clinic