Multimodal Postoperative Pain Management Following Shoulder Arthroplasty
试验速览
- 阶段
- 3 期
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Postoperative shoulder function
研究概览
简要总结
Pain control is a critical after many surgical procedures. It is well known that orthopaedic surgeries are among the most painful procedures, with total joint arthroplasty being a clear example of this situation. Current trends in pain management are morphing and multimodal opioid sparing protocols are now being evaluated and implemented, with results showing a decrease in the amount of opioids being prescribed. Despite all efforts, most patients experience pain and, in order to control it, multiple medications have been tried with variable results. The most commonly prescribed medications are opioids, but side effects associated with their use as well as their addictive potential are making them a less desirable option for patients. Currently there is a trend towards diminishing opioids consumption and prescribing alternative pain control regimens.Caffeine is a well known molecule that when associated with non-steroidal anti-inflammatory drugs (NSAIDS) potentiates their analgesic effect and decreases the amount of doses required to control pain. Little is known about the effect of caffeine over pain relief in patients undergoing total joint arthroplasty, but preliminary results in other fields make us believe it could have a potential benefit for patients undergoing total joint arthroplasty.
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
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients who undergo primary Total Shoulder Arthroplasty or Reverse Total Shoulder Arthroplasty
- •Patient willing and able to complete postoperative surveys
- •Post-Menopausal Women and Men over the age of 55
排除标准
- •Patients reporting caffeine consumption in excess of 300mg daily
- •Patient has known history of opioid addiction, has taken opioids preoperatively, or other forms of substance abuse.
- •Patient has history of cardiac diseases that might be aggravated by the use of caffeine, as diagnosed by a cardiologist or demonstrated by an abnormal EKG.
- •Patient has a known allergy to aspirin or caffeine.
- •Patient has history of cancer, neuropathic pain, or nerve degenerative disease that would affect patient reported outcomes including pain.
- •Patient has history of anxiety disorder
- •Patients with known sleep disturbances that would otherwise be affected by caffeine
- •Patients undergoing revision surgery
- •Patients who require alternate DVT prophylaxis other than ASA.
- •Patients undergoing inpatient arthroplasty
- •Workman's comp patient or patient has current litigation pending
研究组 & 干预措施
Caffeine Group
2 week supply of 100mg caffeine + aspirin 325mg + standard pain regimen (experimental)
干预措施: Total Shoulder Arthroplasty (Procedure)
Caffeine Group
2 week supply of 100mg caffeine + aspirin 325mg + standard pain regimen (experimental)
干预措施: Caffeine Pill (Drug)
Caffeine Group
2 week supply of 100mg caffeine + aspirin 325mg + standard pain regimen (experimental)
干预措施: Percocet 10Mg-325Mg Tablet (Drug)
Caffeine Group
2 week supply of 100mg caffeine + aspirin 325mg + standard pain regimen (experimental)
干预措施: Zofran 4Mg Tablet (Drug)
No Caffeine Group
aspirin 325mg + standard pain (control)
干预措施: Total Shoulder Arthroplasty (Procedure)
No Caffeine Group
aspirin 325mg + standard pain (control)
干预措施: Percocet 10Mg-325Mg Tablet (Drug)
No Caffeine Group
aspirin 325mg + standard pain (control)
干预措施: Zofran 4Mg Tablet (Drug)
结局指标
主要结局
Postoperative shoulder function
时间窗: 24 weeks
This will be measured using the American Shoulder and Elbow Surgeon Survey (ASES)
Postoperative Pain
时间窗: 15 days
This will be measured using the Visual Analog Scale for Pain (VAS) survey
postoperative shoulder function
时间窗: 24 weeks
This will be measured using the Simple Shoulder Test (SST) which consist of 12 questions
次要结局
未报告次要终点