The Use of Venlafaxine in Reducing Acute Post-Surgical Pain and Opioid Consumption in Primary Total Knee Replacement
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Cumulative 24 hour total opioid consumption
研究概览
简要总结
Patients experience pain after their knee replacement surgery - and some may continue to experience persistent pain long after their knee replacement surgery. Traditional pain management strategies reply on pain medication such as opioids for pain control. However, these drugs do not work well for pain associated with movement or the the nerve pain (tingling, electrical sensations) after surgery. In addition, opioids are associated with significant side effects such as nausea, vomiting, respiratory depression, depression, cognitive dysfunction and risk of persistent opioid use. Neuropathic pain medications, such as venlafaxine are effective in managing nerve pain. Recent studies also support its potential role in acute pain management. Here, we propose a prospective randomized clinical trial 1) to evaluate the efficacy of Venlafaxine in reducing pain intensity and opioid consumption at post-operative day 1 (POD1) and 1- week after surgery, and 2) to examine whether the use of Venlafaxine will reduce the incidents of chronic postsurgical pain in TKA patients at 3-month time point.
详细描述
Patients meeting the inclusion criteria will be randomized to receive either Venlafaxine extended release (ER) 37.5 mg/d or a placebo on the day of surgery and continue the treatment for 7 days after surgery. The primary outcomes include pain severity score (numeric rating scale, NRS) and consumption of morphine miligram equivalent (MME) at 24 hours. The secondary outcome will measure MME and NRS at postoperative day 7. In addition, the disability scale and perceived function 3 months after surgery will be compared to the baseline level by using PROMIS (Patient-Reported Outcomes Measurement Information System)10 Global Health, KOOS, JR. (Knee injury and Osteoarthritis Outcome Score Short Form), and VR-12 (Veterans RAND 12 Item Health Survey) Scale.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adult (male and female) subjects aged 18 to 75,
- •English speaking,
- •are scheduled for primary total knee arthroplasty with planned spinal anesthesia with saphenous peripheral nerve block at the adductor canal.
排除标准
- •general anesthesia,
- •hepatic & renal failure,
- •history of diabetic peripheral neuropathic pain,
- •chronic opioid use,
- •concurrent use of antidepressants, triptans, and/or linezolid,
- •allergy to the study medications,
- •prior knee surgery,
- •BMI > 40,
- •bleeding disorders,
- •history of recent falls,
- •concurrent benzodiazepine use.
研究组 & 干预措施
Placebo
Subjects in placebo arm will receive inactive placebo capsule daily for 7 consecutive days starting on day of primary arthroplasty surgery.
干预措施: Placebo (Drug)
Venlafaxine
Subjects in venlafaxine arm will receive venlafaxine 37.5mg daily for 7 consecutive days starting on day of primary arthroplasty surgery.
干预措施: Venlafaxine 37.5 MG (Drug)
结局指标
主要结局
Cumulative 24 hour total opioid consumption
时间窗: 24 hours
morphine miligram equivalent
次要结局
- Pain numeric rating scale at 24 hours post operatively(24 hours)
- Pain severity and interference at 7 days post operatively(7 days)
- Pain severity and interference at 3 months post operatively(3 months)
- Functionality at 7 days postoperatively(7 days)
- Functionality at 3 months postoperatively(3 months)
- Opioid consumption at 7 days postoperatively(7 days)
- Opioid consumption at 3 months postoperatively(3 months)