Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- NRS Pain With Ambulation at 2 Weeks
研究概览
简要总结
We are investigating the impact of duloxetine ("Cymbalta"), a serotonin and norepinephrine reuptake inhibitor, on pain after total knee arthroplasty (TKA). Specifically, the investigators will determine whether duloxetine, 60 mg daily for 2 weeks, reduces pain scores 2 weeks after TKA.
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
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with osteoarthritis scheduled for primary tricompartmental total knee arthroplasty with a participating surgeon
- •Age 25 to 75 years
- •Planned use of regional anesthesia
- •Ability to follow study protocol
- •English speaking (primary outcome obtained via telephone call and secondary outcomes include questionnaires validated in English only)
- •Patients planning on being discharged home or to a rehabilitation center that has agreed to participate
排除标准
- •Concurrent use of duloxetine or other SNRIs, MAOIs, Tricyclic antidepressants, triptans (sumatriptan, rizatriptan, naratriptan, zolmitriptan, eletriptan, almotriptan, frovatriptan), lithium, buspirone, St. John's Wort
- •Hepatic insufficiency
- •Renal insufficiency
- •Patients younger than 25 years old and older than 75
- •Patients intending to receive general anesthesia
- •Allergy or intolerance to one of the study medications
- •Patients with an ASA of IV
- •Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
- •Chronic opioid use (taking opioids for longer than 3 months)
- •Patients with major prior ipsilateral open knee surgery
研究组 & 干预措施
Control
Patients will receive 0mg of duloxetine
干预措施: Placebo (Drug)
Duloxetine
Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.
干预措施: Duloxetine 60mg (Drug)
结局指标
主要结局
NRS Pain With Ambulation at 2 Weeks
时间窗: 2 weeks after surgery
When considering the pain in the knee in which you are having/had surgery, on a scale of 0-10, with 0 being no pain and 10 being pain as bad as you can imagine, how would you describe your level of pain in the last 24 hours during ambulation?
次要结局
- Total Daily Opioid Use (mg Oral Morphine Equivalents)(POD 1)
- Nausea Severity(POD 1)