A Randomized Controlled Study on Acupuncture for Perioperative Pain After Open Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Postoperative pain intensity measured by Numeric Rating Scale (NRS-11)
研究概览
简要总结
Acupuncture has been shown in several meta-analyses and clinical studies, in different surgical settings and chronic back pain, to be a safe adjuvant option for postoperative pain treatment. In this study, the investigator hypothesize that acupuncture can decrease postoperative pain intensity and amount of given analgesics, and accelerate recovery of bowel motility, in patients after open radical prostatectomy.
The investigator will also investigate whether or not acupuncture with needle skin penetration is more efficacious than acupressure.
详细描述
This study will be a randomized, controlled and partially blinded study with three arms: 1) press tack needle acupuncture (ACU) and routine postoperative analgesic care, 2) press tack placebo acupressure (SHAM) and routine postoperative analgesic care, and 3) only routine postoperative analgesic care (CONTROL).
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males aged 18-70 years
- •Diagnosis with prostate cancer and scheduled for open radical prostatectomy
- •Ability and willingness to follow study instructions and complete all required questionnaires during hospitalization and follow-up
- •Written informed consent
排除标准
- •Inability to understand the terms of this study
- •Simultanously participation in other clinical trials possibly influencing primary or secondary endpoints or any acupuncture-related clinical trials within 30 days prior to inclusion
- •Prior surgery within the last three months
- •Received acupuncture within 6 weeks before surgery
- •Known hypersensitivity or fear of acupuncture
- •Known abuse of drugs, medications and alcohol
- •Chronic pain for more than 3 months
- •Continuous opioid analgesic medications for more than 3 days during the 4 weeks prior to surgery
结局指标
主要结局
Postoperative pain intensity measured by Numeric Rating Scale (NRS-11)
时间窗: postoperative day three
The primary outcome is to check the effects of permanent needle acupuncture at 6 acupuncture points for changing postoperative pain intensity as measured by the Numeric Rating Scale (NRS-11), calculated as area under the curve (AUC).
次要结局
- EQ-5D-5L for quality of life(7 days after catheter removal)
- Time to first defecation following surgery(postoperative day three)
- Cumulative use (sum in mg) of routine postoperative analgesics(postoperative day three)