Efficacy of Transcutaneous Electrical Acupoint Stimulation on Postoperative Pain and Recovery in Patients Undergoing Pancreatectomy: a Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 132
- 主要终点
- highest NRS pain score for movement-evoked pain (defined as deep breathing or forced coughing three times) during 72 hours postoperatively.
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 pancreatectomy
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), Zusanli (ST 36), Hegu (L14) and Waiguan (SJ5) acupoints. The treatment will consist of two phases: a 30-minute stimulation administered 30 minutes before anesthesia induction, and a 30-minute stimulation session once daily on postoperative days 1, 2, and 3. 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 class I - III; Patients scheduled for pancreatectomy.
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; Have a history of Transcutaneous Electrical Acupuncture Stimulation (TEAS) or electroacupuncture treatment in the past or recently；
结局指标
主要结局
highest NRS pain score for movement-evoked pain (defined as deep breathing or forced coughing three times) during 72 hours postoperatively.
时间窗: Up to 72 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, and 10 points representing the strongest pain.
次要结局
- the highest NRS pain score at rest during 72 h postoperatively(Up to 72 hours postoperatively)
- The cumulative morphine consumption at 24, 48, and 72 hours postoperatively.(Up to 72 hours postoperatively)
- The incidence of postoperative nausea and vomiting during the first 24,48,72 hours.(Up to 72 hours postoperatively)
- The incidence of a composite of postoperative pulmonary complications during hospitalization.(Up to 7 days postoperatively)
- Quality of Recovery Scale Score at 24, 48, and 72 hours after surgery.(Up to 3 days postoperatively)
- The postoperative sleep quality score(Up to 3 days postoperatively)
- The plasma levels of C-reactive protein (CRP), procalcitonin (PCT), beta-endorphin, serotonin (5-HT), interleukin-2 (IL-2), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α) on the 1st, 3rd, and 5th postoperative days(Up to 5 days postoperatively])
研究者
Chunling Jiang
Professor
West China Hospital