Efficacy of Transcutaneous Electrical Acupoint Stimulation on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy：a Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 524
- 试验地点
- 1
- 主要终点
- The incidence of moderate to severe pain (NRS ≥ 4) during movement (i.e. cough or take three deep breaths) at 24 hours after surgery
研究概览
简要总结
The purpose of this study is to access the effect of transcutaneous electrical acupoint stimulation on postoperative pain in patients undergoing hepatectomy
详细描述
Patients who meet the enrollment criteria will be randomized 1:1 to either the transcutaneous electrical acupoint stimulation (TEAS#or the sham groups. In the TEAS group, the acupoints are bilateral neiguan (PC6) , Hegu(L14), Yanglingquan(GB34), Zusanli(ST 36) and Renying(ST9) acupoints. Patients will receive TEAS 30min before anesthesia until being discharged from the post-anaesthesia care unit (PACU). The same treatment for 30 min will be performed on the 1st, 2nd and 3rd days after surgery.The stimulation intensity will be adjusted in accordance with the maximal level tolerated by each patient.
Patients in the sham group will receive electrode attachment but without stimulation.
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, Outcomes Assessor)
盲法说明
Blinding of participants will be maintained throughout the observation period. The sham group will receive electrode attachment but without stimulation,Throughout the study, for adequate blinding, an opaque tape will be applied to the patient's skin above the electrodes, and the patient's target acupoints will be wrapped in a blanket. All patients will be informed that they might or might not feel a tingling sensation around the acupoints when the TEAS device is working. The patients should not be unblinded until the statistical analysis of the study data is completed.
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
- •Age 18-80 years old; ASA physical status classⅠ-Ⅲ; Patients scheduled for elective hepatectomy.
排除标准
- •Have a history of epilepsy; Rash or local infection over the acupoint stimulation skin area; Pregnancy or breastfeeding; Mental retardation, psychiatric, or neurological disease; Inability to comprehend the numeric rating scale (NRS); Implantation of a cardiac pacemaker, cardioverter, or defibrillator; Chronic opioid use; Metastases in other organs;
研究组 & 干预措施
TEAS group
Patients who meet the enrollment criteria will be randomized 1:1 to either the transcutaneous electrical acupoint stimulation (TEAS#or the sham groups. In the TEAS group, the acupoints are bilateral neiguan (PC6) , Hegu(L14), Yanglingquan(GB34), Zusanli(ST 36) and Renying(ST9) acupoints. Patients will receive 30min TEAS before anesthesia until be discharged from the post anaesthesia care unit (PACU). The same treatment for 30 min will be performed on the 1st, 2nd and 3rd days after surgery.The stimulation intensity will be adjusted in accordance with the maximal level tolerated by each patient.
干预措施: transcutaneous electrical acupoint stimulation (Device)
sham group
Patients in the sham group will receive electrode attachment but without stimulation.
干预措施: sham transcutaneous electrical acupoint stimulation (Device)
结局指标
主要结局
The incidence of moderate to severe pain (NRS ≥ 4) during movement (i.e. cough or take three deep breaths) at 24 hours after surgery
时间窗: Up to 24 hours postoperatively
The pain is evaluated using numerical rating scale(NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, 1-3 points representing mild pain, 4-6 points representing moderate pain, 7-9 points representing severe pain and 10 points representing the strongest pain.
次要结局
- Pain scores of movement-evoked pain at postoperative 24,48 and 72 hours(Up to 72 hours postoperatively)
- Pain scores of pain at rest at 24, 48 and 72 hours postoperatively(Up to 72 hours postoperatively)
- The incidence of moderate to severe pain (NRS ≥ 4) at rest at 24, 48 and 72 hours after surgery(Up to 72 hours postoperatively)
- The incidence of moderate to severe pain (NRS ≥ 4) during movement (i.e. cough or take three deep breaths) at 48 and 72 hours after surgery(Up to 72 hours postoperatively)
- The incidence of a composite of postoperative pulmonary complications during hospitalization(immediately after the end of surgery, and at the first 24 hours after surgery)
- Length of hospital stay(From admittance to discharge)
- The incidence of chronic postsurgical pain (CPSP)(3 months after surgery)
- The incidence of postoperative nausea and vomiting during the first 24,48,72 hours(Up to 72 hours postoperatively)
- Quality of Recovery Scale Score at 24, 48, and 72 hours after surgery(Up to 72 hours postoperatively)
- Time of Bowel function recovery(Up to 72 hours postoperatively)
- The cumulative morphine consumption at 24, 48, and 72 hours postoperatively(Up to 72 hours postoperatively)
- The postoperative sleep quality score(Up to 72 hours postoperatively)
- The anxiety and depression scores(Up to 72 hours postoperatively)
研究者
Chunling Jiang
Professor
West China Hospital