Minimizing Post-surgical Pain and Narcotic Administration Through Cryotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Change in postoperative pain score
研究概览
简要总结
Postoperative pain is an unavoidable consequence of open abdominal surgery. Although cryotherapy, the application of ice to a surgical wound site, has been shown to be effective in reducing postoperative pain in orthopedic, gynecologic, and hernia operations, it has not been assessed in patients who undergo major open abdominal operations. We hypothesized that patients who receive cryotherapy would report lower pain scores as a primary outcome measure. This would result in less narcotic analgesia usage, and shorter hospital stays as secondary outcome measures.
详细描述
Objectives:
This study will attempt to assess the impact of cryotherapy on post-surgical inflammation and narcotic use. End-points for the study will be patient use of narcotics and pain level, regularly measured by nursing staff.
Patient Selection:
This study will accept all consecutive consenting patients who visit the Grady Hospital and Emory University urology clinics who require abdominal surgery.The study will require 55 patients, based on prior power calculations.
Registration/Randomization:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any open transperitoneal abdominal surgery with a midline incision
排除标准
- •Additional surgeries required
研究组 & 干预措施
Cryotherapy
Patients in the cryotherapy study group will have ice packs placed on their abdominal wound for the first hour following surgery.
干预措施: Ice pack (Other)
Control
No adjunctive therapy following abdominal surgery.
结局指标
主要结局
Change in postoperative pain score
时间窗: Participants will be followed for the duration of hospital stay, an average of 7 days
Throughout the hospital stay nurses will assess patients pain levels. Patients will complete a visual analog score one hour postoperatively and then at 8am and 4 pm each day.
次要结局
- Narcotic use(Participants will be followed for the duration of hospital stay, an average of 7 days)
研究者
Viraj Master
Director of Clinical Research Unit
Emory University