NCT06024200招募中不适用
Effect of Whole-process Transcutaneous Electrical Acupoint Stimulation on Opioid Consumption After Gastrointestinal Laparoscopic Surgery: a Prospective, Randomised, Blinded, Placebo-controlled Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- The total sufentanil consumption postoperatively
研究概览
简要总结
The goal of this clinical trial is to evaluate the effect of whole-process transcutaneous electrical acupoint stimulation on opioid consumption after gastrointestinal laparoscopic surgery. All subjects received conventional multimodal analgesia. On this basis, the experimental group received whole-process transcutaneous electrical acupoint stimulation, while the control group received corresponding false stimulation.
详细描述
Conventional multimodal analgesia protocols as follows：
- Before the end of the operation, the surgical incision was infiltrated with 0.5% ropivacaine 10 mL locally.
- Patients were transferred to the PACU and provided with patient-controlled intravenous analgesia with sufentanil for postoperative analgesia. The analgesia devices were set to a concentration of 1ug/mL, with a lockout interval of 15 minutes, and a 3 mL bolus，without an infusion dose. The pump was withdrawn 72h after surgery.
- Flurbiprofen: 50mg per dose intravenously twice a day for postoperative three days.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18 years or older;
- •scheduled for elective laparoscopic gastrointestinal surgery；
- •informed consent；
- •American Society of Anesthesiologists Physical Status Grades I-III；
- •body mass index (BMI) between 18.5 kg/m2 and 28 kg/m2
排除标准
- •local skin infection, incision or scar near the study acupoints;
- •nerve damage in upper or lower limbs;
- •participation in other clinical trials that influence the evaluation of the results of this study;
- •inability to understand the Visual Analog Scale (VAS) score or disagreeing with the use of patient controlled analgesia;
- •presence of a pacemaker;
- •patients with severe CNS diseases or severe mental disorders;
- •operations requiring enterostomy or converts to laparotomy;
- •patients who need to be transferred to the intensive care unit (ICU) for treatment after surgery.
结局指标
主要结局
The total sufentanil consumption postoperatively
时间窗: 3 days
measured from the recovery area until postoperative day 3
次要结局
- The number of postoperative rescue analgesia(7 days)
- Neutrophil ratio（NEUT）(3 days)
- Pain scores (VAS)(4 days)
- Pain Catastrophizing(5 days)
- Quality of recovery(5 days)
- The variation of C-reactive protein（CRP）(3 days)
- The variation of white blood cell count （WBC）(3 days)
- Time to first ambulation(up to 7 days)
- Satisfaction score with pain management(7 days)
- Procalcitonin（PCT）(3 days)
- Time to first flatus(up to 7 days)
- Time to first defecation(7 days)
- Time to first feed(up to 7 days)
- The incidence rate of adverse reaction(7 days)
研究者
研究点 (1)
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