A New Treatment Modality for the Postoperative Muscular Pain Management in Pylorus Preserving Pancreaticoduodenectomy: a Double-blind Randomized Control Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Pain: VAS (visual analogue scale)
研究概览
简要总结
Pancreaticoduodenectomy is inevitably an operation requiring extensive skin and muscle incision, resulting in postoperative pain resulting in limitation of the patient's early exercise and function. ETOIMS(Electrical Twitch Obstructive Intramuscular Stimulation) is used to relieve muscle pain and relax muscles. ETOIMS is a method to relieve pain by stimulating muscle in myofascial pain syndrome. ETOIMS as an effective new treatment for pain after pylorus preserving pancreaticoduodenectomy.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing pancreatoduodenectomy in Gangnam Severance Hospital, Seoul, Korea
- •Patients who are able to perform daily activities before surgery and were able to walk independently.
- •Adults over 20
排除标准
- •Patients with history of previous open surgery
- •Patients who are not able to exercise due to severe musculoskeletal pain except surgery-related diseases
- •Patients who can not walk because of difficulty breathing related to myalgia
- •Patients who can not exercise due to severe musculoskeletal pain
- •Patients who had a limb defect before surgery and were unable to walk without assistive devices and others
- •Pregnant / lactating mothers
- •Patients who have cognitive impairment and can not answer the questionnaire
- •Patients with Pacemaker
- •Patients who can not read the consent form
结局指标
主要结局
Pain: VAS (visual analogue scale)
时间窗: AM 7:00 morning at Preoperative day and the day following surgery before discharge (Postoperative day 1 - Postoperative day 10)
The primary outcome of this study was the postoperative pain score (VAS score) in patients undergoing ETOIMS during surgery. The type of surgery in the experimental group and the control group is the same and the same analgesic agent (IV PCA, Wound PCA) is used. The pain score is measured at 7 o'clock every morning from the day following surgery to discharge (about Postoperative day 10) to confirm the reduced pattern.
次要结局
未报告次要终点
研究者
Joon Seong Park
Professor,
Yonsei University