Influence of Intraoperative Opioids (Oxycodone/Fentanyl) Usage on the Post-operative Pain Management of Peroral Endoscopic Myotomy (POEM)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 196
- 主要终点
- post-operative pain condition
研究概览
简要总结
Peroral endoscopic myotomy (POEM) is a minimally invasive treatment for esophageal achalasia with a natural orifice transluminal endoscopic procedure and far less invasive than the standard surgical or laparoscopic Heller myotomy (LHM). Less is known about the postoperative pain after POEM and the minor surgery trauma, short length of stay may lead to underestimation of postoperative pain control. We tend to observe the pain status after the POEM surgery under the empirical treatment in our center, and find a proper intra-operative way of pain control to solve the post-operative pain and seek the possible influence factors of postoperative 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Achalasia patients undergoing elective POEM surgery
- •age 18-80
- •BMI 18-30 kg/m2
排除标准
- •Patient refusal
- •abnormality of liver and kidney function in patients
- •patients with mental disorder, language disorder, and other patients who can not cooperate with and complete the follow-up and questionnaire pre- and post- operatively
- •patients (including propanotamo, propofol, lidocaine, and other drugs) against drug taboos in the anesthetic scheme
- •patients with chronic pain before operation with analgesic drugs
研究组 & 干预措施
fentanyl
the patients use remifentanil and fentanyl as intra-operatively pain control and compare the post-operative pain condition with the oxycodone group
干预措施: Fentanyl (Drug)
oxycodone
the patients use oxycodone and remifentanil as intra-operatively pain control and compare the post-operative pain condition with the fentanyl group
干预措施: Oxycodone (Drug)
结局指标
主要结局
post-operative pain condition
时间窗: 36 hours after the POEM surgery
use Visual Analogue Scale/Score(0-10) to record post operative pain
post-operative sleep quality
时间窗: 48 hoursafter the surgery
Postoperative sleep quality was investigated with a self-reported sleep questionnaire including 6 yes/no questions(0-6) with full score 6 represented the worst sleep
post-operative PCA usage volumn
时间窗: 36 hours after the POEM surgery
record PCA usage volumn(ml) to see the dosage of opiods used after the surgery
次要结局
- chronic pain condition(28 days after discharge)
研究者
Chen Wannan
Principal Investigator
Shanghai Zhongshan Hospital