The Efficacy of Continuous Cold-Therapy on Postoperative Pain and Narcotics Use Following Spinal Fusion
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Postoperative Pain
研究概览
简要总结
Patient outcomes and satisfaction are an ever-increasing priority in surgical specialties. Cryotherapy has been utilized following spine surgery as an adjunct therapy to reduce postoperative inflammation and improve patient outcomes. However, limited studies have investigated the effect of cryotherapy on postoperative pain and narcotics use. Fountas et al. performed a randomized controlled trial to assess the impact of postoperative cryotherapy following single-level lumbar microdiscectomy. The authors reported patients receiving cryotherapy required significantly less pain medication (0.058 mg/kg/hr versus 0.067 mg/kg/hr, p<0.001) and had shorter hospital stays (1.71 days versus 2.65 days, p<0.001) as compared to the control group. In another randomized trial of single-level lumbar discectomy patients, Murata et al. demonstrated cryotherapy to have no significant effect on VAS inpatient pain scores or postoperative blood loss.
详细描述
The purpose of this study is to determine if postoperative cryotherapy with a cold-therapy system reduces postoperative pain and narcotic consumption following single and multi-level spinal fusion.
The investigators hypothesize that patients undergoing lumbar spinal fusion who receive postoperative cryotherapy treatment with a cold-therapy system will have reduced inpatient pain scores and require less narcotics as compared to patients that receive standard care (ice pack).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Single or multi-level lumbar spinal fusion for degenerative pathology, including: radiculopathy, central spinal stenosis, foraminal stenosis, herniated nucleus pulposus, degenerative disc disease, and isthmic or degenerative spondylolisthesis.
- •Patient able to provide informed consent
排除标准
- •Chronic preoperative narcotic use defined as daily narcotic use for the past 6 months prior to surgery
- •Workers' compensation insurance claim
- •Active or history of malignancy
- •Unable to speak, read, or comprehend English language
结局指标
主要结局
Postoperative Pain
时间窗: 2 year postoperative
Average daily Visual Analog Scale (VAS) survey, which measures pain, for the duration of hospital stay and postoperative VAS scores will be recorded for 2 years postoperatively. This information will be collected through a survey that will be administered upon patient discharge. Patients will be asked to return the completed survey to the research team. VAS scale ranges from 0 - 100 mm, with 100 representing maximum pain and 0 representing no pain.
Narcotics Consumption
时间窗: 2 weeks postoperative
Total, daily, and hourly narcotics consumption during the hospitalization. Narcotic consumption will be recorded for 2 weeks following discharge. Patients will be asked to report the number of narcotic pills taken each day. This information will be collected through a survey that will be administered upon patient discharge. Patients will be asked to return the completed survey to the research team.
次要结局
- Bony fusion(2 year postoperative)
- Disability(2 year postoperative)
- Physical Function: Patient-Reported Outcomes Measurement Information System (PROMIS)(2 year postoperative)
- Disposition on discharge(Up to 2 weeks)
- Length of Stay(Up to 2 weeks)
- General Health Status: Short-Form (SF-12)(2 year postoperative)