Comparison of Continue Cryotherapy and Standard Ice Packs for Pain Reduction Following Total Shoulder Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Continuous monitoring of pain control
研究概览
简要总结
This is a randomized prospective study to test if cooling therapies decrease narcotic pain medication use in patients following total shoulder replacement surgery (total shoulder arthroplasty, TSA). Postoperative standard care involves use of ice packs placed on the surgical site for periods of approximately 20 minutes every 2 hours, but they do not provide consistent temperature and can become uncomfortably cold. Continuous cryotherapy (CC) machines provide flow of continuous cooled water (45-55° F) via a cuff placed on the affected sight for several hours. There are mixed results as to whether CC is more beneficial than standard ice pack therapy. This study will address whether CC decreases pain and narcotic pain medication use compared to ice pack therapy in TSA patients. The investigators will monitor both patient-reported pain scores and actual narcotic use to test the hypothesis that use of CC reduces postoperative pain and the need for narcotic pain medication. The results of this study may help establish parameters for non-pharmacologic intervention to reduce patient reliance on narcotic medications.
详细描述
Prior to the surgical procedure, the patients will be met by one of the coinvestigators or Dr. Williams in the preoperative holding area. At this time, the patients will be administered a questionnaire about their current pain level using a Visual Analog Scale (VAS) of 0-10, where 0 is no pain and 10 is the worse pain imaginable. The questionnaire will be the same questionnaire used after surgery, so questions referencing ice use will be disregarded for this initial interview. After all questions have been answered, patients will receive an interscalene block by the anesthesiology team prior to being brought to the operative suit. Interscalene block routinely performed prior to shoulder arthroplasty at our institution.
At the conclusion of the surgery, a randomly assigned envelope indicating the arm of the study will be opened. At that time, the indicated therapy (ice pack or CC) will be initiated. Ice packs and CC machines will be available and readily accessible for nursing staff to assist study participants. The CC group will use the following protocol:
The CC will be initiated immediately after surgery, with application of the CC cuff in the OR. Temperature will be set to between 45-55°F. The machine will be worn continuously for the first 72 hours postoperatively. The machine is portable and can be taken with the patients as they move about the hospital/home. After the first 72 hours CC will be used as needed. Patients will be encouraged to use the CC whenever their pain is rated 4-5 on the VAS. Prior to discharge, the patient will be instructed on machine use and the at home protocol. The protocol includes when to wear the machine and how to record CC and narcotic use. Written instructions for the protocol and a diary for recording usage will be provided to the patient. The patients will document the time and duration the machine is in use, along with their pain prior to and after use. The protocol will continue through postoperative day 28. Data collection will end a postoperative day 28, though patients may continue to use the machine longer if they choose.
The standard ice therapy group will use the following protocol:
The standard ice therapy will be initiated immediately post-operatively. While in the hospital, ice will be applied for 20 minutes every 2 hours. Upon discharge, ice pack therapy will be applied for 20 minutes every 2 hours while awake. (Patient do not need to wake up every 2 hours to apply ice at night.) After 72 hours post-operative, patient may apply ice therapy for 20 minutes as needed, in 2 hour time increments. Patients will be encouraged to use the ice whenever their pain is rated 4-5 on the VAS. Prior to discharge, the patient will be instructed about ice pack use and the at home protocol. The protocol includes when to use ice and how to record ice usage and narcotic use. Written instructions for the protocol along with a diary will be provided to the patient. Subjects will document the time and duration the standard ice therapy is in use along with their pain prior to and after usage. This will be continued until postoperative day 28, when data will stop being collected. The patient may continue to use icepacks after postoperative day 28 if they choose.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between the age of 55 and 80 who are indicated for a TSA, including both anatomic (maintaining anatomic location of the ball and socket in the shoulder) and reverse (reverses where the ball and socked are placed) total shoulder arthroplasties.
排除标准
- •Patients undergoing:
- •revision total shoulder arthroplasty
- •TSA for a fracture
- •Patients with a history of narcotic abuse.
- •Patients unwilling or unable to receive and interscalene block
- •Patients with Raynaud's disease, vasospastic disease, or other circulatory dysfunction
- •Patients with cold hypersensitivity, decreased skin sensitivity related to temperature
- •Patients with central ports, PICC lines, or other indwelling IV access on the affected side.
结局指标
主要结局
Continuous monitoring of pain control
时间窗: Up to post operative day 28
Pain control will be self reported using a visual analog scale (VAS) for pain. The scale will be from 1 to 10 with 1 being being less severe pain and 10 being more severe pain
Continuous monitoring of narcotic use
时间窗: Up to post operative day 28
Subjects will record narcotic post operatively and this will be converted to morphine equivalents.
次要结局
未报告次要终点
研究者
D. Patrick Williams
Assistant Professor
University of Pittsburgh