Remote Ischemic Preconditioning (RIPC) and Its Effect on the Postoperative Pain Experience Following Intra-abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Comparison of Pain Intensity and Unpleasantness Postoperatively
研究概览
简要总结
Remote Ischemic PreConditioning (RIPC) will improve the postoperative pain experience in patients undergoing abdominal surgery. Although abdominal surgery can be a lifesaving procedure many people have a significant amount of postsurgical pain. Severe postsurgical pain may lead to chronic pain in some people. "Remote Ischemic Preconditioning" may reduce the amount of postsurgical pain. Remote ischemic preconditioning is done by inflating a balloon (very similar to a blood pressure cuff) on the leg until it blocks blood flow for a few minutes. The cuff is then deflated and blood flow resumes. The process is repeated up to three times. This procedure causes the body to increase its natural pain relief system that may help to decrease the amount of postsurgical pain.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing elective open intra-peritoneal surgery
- •Able to provide written informed consent to participate
- •Laparoscopic abdominal surgery
排除标准
- •Ongoing Workman's Compensation claim
- •>50mg/day of oral morphine or morphine equivalent
- •Currently being treated for lower extremity DVT
- •Known intracranial hypertension (not excluding patients with a functioning VP shunt)
- •Known Hypercoagulable state (e.g. factor V Leiden, protein s or c deficiency)
- •Ongoing localized thigh pain
- •Planned epidural analgesia
- •Any DSM IV-R Axis I psychotic disorders
- •Unable to understand English
- •Unable to understand the consent form
结局指标
主要结局
Comparison of Pain Intensity and Unpleasantness Postoperatively
时间窗: Postoperative day 1 and postoperative day 2
Pain intensity and unpleasantness will be measured on postoperative day (POD) 1 and 2 by using a 0-10 verbal scale after asking the subject to cough. Higher scores denotes more intensity and unpleasantness of pain.
次要结局
- Use of Antiemetics(Postoperative day 1 and postoperative day 2)
- Consumption of Nonopioid Analgesics(Postoperative day 1 and postoperative day 2)
- Number of Participants That Consumed Opioids(Postoperative day 1 and postoperative day 2)
- Leg Pain at 48 Hours(postoperative day 2)
- Patient Verbal Assessment as to Whether They Received Active Treatment or Placebo(Postoperative day 1 and postoperative day 2)
- Level of Sedation(Postoperative day 1 and postoperative day 2)
- McGill Pain Sensory(Postoperative day 1 and postoperative day 2)
- Pain Unpleasantness(Postoperative day 1 and postoperative day 2)