Effect of Whole-process Transcutaneous Electrical Acupoint Stimulation on Opioid Consumption After Gastrointestinal Laparoscopic Surgery: a Prospective, Randomised, Blinded, Placebo-controlled Study
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 The pump was withdrawn 72h after surgery.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.
研究组 & 干预措施
whole-process transcutaneous electrical acupoint stimulation
Electrical stimulation is performed within 24h before surgery, 30min before anesthesia induction and 3 days after surgery, each stimulation was 30min. Patients are treated bilaterally at two groups of distal acupoints: one group consisted of Hegu (LI4) and Neiguan (PC6), the other contained Zusanli (ST36) and Shanyinjiao (SP6). Stimulation is delivered with adisperse-dense wave, 2Hz in frequency. The stimulation intensity is adjusted in accordance with the maximal level tolerated by each patient.
干预措施: transcutaneous electrical acupoint stimulation (Other)
whole-process transcutaneous electrical acupoint stimulation(sham stimulation)
Patients are treated bilaterally at four sham acupoints of LI4, PC6, ST36 and SP6. These four pseudo-acupoints were located 1 cun ulnarlateral, and 7 cun and 9 cun proximal to Shenmen (HT7) ;and 9 cun and 12 cun proximal of Kunlun (BL60). These sham points are picked because there are no meridians or channels through these four sites. The stimulation intensity is adjusted in the lowest level felt by each patient. Other intervention details are similar to those of the experimental group.
干预措施: transcutaneous electrical acupoint stimulation sham stimulation (Other)
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
- Time to first flatus(up to 7 days)
- The number of postoperative rescue analgesia(7 days)
- Neutrophil ratio（NEUT）(3 days)
- Pain Catastrophizing(5 days)
- Quality of recovery(5 days)
- Pain scores (VAS)(4 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 defecation(7 days)
- Time to first feed(up to 7 days)
- The incidence rate of adverse reaction(7 days)