Effect of Transcutaneous Electrical Acupoint Stimulation Combined With Oxycodone on Postoperative Visceral Pain and Early Recovery Quality in Gynecologic Laparoscopic Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- the VAS score of postoperative visceral pain
研究概览
简要总结
To investigate the effect and feasibility of percutaneous acupoint stimulation combined with oxycodone on postoperative visceral pain in laparoscopic patients, and provided a clinical basis for optimizing perioperative pain management in laparoscopic patients.
详细描述
Patients aged 18-65 years old, BMI 18-30kg/m2, ASA grade I or II were selected for gynecologic laparoscopic surgery (laparoscopic ovarian tumor stripping, laparoscopic uterine fibroid stripping, laparoscopic total hysterectomy) under general anesthesia from May 2024 to July 2024. Exclusion criteria: Patients who were allergic to the drugs used in the study, had confusion or cognitive impairment, contraindicated percutaneous acupoint electrical stimulation, abnormal cardiopulmonary and liver and kidney function, history of analgesic drug use within one week, history of diabetes, myocardial infarction, or cerebrovascular accident. Exclusion criteria: patients dropped out of the experiment midway or the data was not completely collected, the surgical method changed midway, the operation duration was less than 30 minutes or more than 2 hours, and patients with opioid and addictive drug dependence
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-65 years
- •American Society of Anesthesiologists grade I-II
- •Body mass index (BMI) 18.5-30 kg/m2;
- •No ulceration or infection at the acupuncture stimulation site.
排除标准
- •Allergic to the drugs used in the study;
- •People with unclear consciousness or cognitive dysfunction;
- •There are contraindications of percutaneous acupoint electrical stimulation;
- •Abnormal cardiopulmonary and liver and kidney function;
- •History of analgesic drug use within one week;
- •History of diabetes, myocardial infarction or cerebrovascular accident.
研究组 & 干预措施
TEAS combined with Oxycodone
Bilateral Neiguan point (PC6), Zusanli point (ST36) and Sanyinjiao point (SP6) were selected. Use Huatuo electronic needle therapy device, Sulodine electric stimulation hand circle TEAS, Huatuo electronic needle therapy device parameter setting: Density wave, 2/10Hz, current intensity from weak to strong, until the patient can tolerate the maximum intensity (acid, numbness, distension, pain) is appropriate, after the Sulodine brand electrical stimulation bracelet is turned on, gradually increase the stimulation intensity, until the patient can tolerate the maximum intensity is appropriate, stimulation for 30min until anesthesia induction; Oxycodone 0.1mg/kg was injected intravenously 5 minutes before anesthesia induction
干预措施: TEAS (Other)
TEAS combined with Oxycodone
Bilateral Neiguan point (PC6), Zusanli point (ST36) and Sanyinjiao point (SP6) were selected. Use Huatuo electronic needle therapy device, Sulodine electric stimulation hand circle TEAS, Huatuo electronic needle therapy device parameter setting: Density wave, 2/10Hz, current intensity from weak to strong, until the patient can tolerate the maximum intensity (acid, numbness, distension, pain) is appropriate, after the Sulodine brand electrical stimulation bracelet is turned on, gradually increase the stimulation intensity, until the patient can tolerate the maximum intensity is appropriate, stimulation for 30min until anesthesia induction; Oxycodone 0.1mg/kg was injected intravenously 5 minutes before anesthesia induction
干预措施: Oxycodone (Drug)
TEAS
Bilateral Neiguan point (PC6), Zusanli point (ST36) and Sanyinjiao point (SP6) were selected. Use Huatuo electronic needle therapy device, Sulodine electric stimulation hand circle TEAS, Huatuo electronic needle therapy device parameter setting: Density wave, 2/10Hz, current intensity from weak to strong, until the patient can tolerate the maximum intensity (acid, numbness, distension, pain) is appropriate, after the Sulodine brand electrical stimulation bracelet is turned on, gradually increase the stimulation intensity, until the patient can tolerate the maximum intensity is appropriate, stimulation for 30min until anesthesia induction; The same amount of normal saline was injected intravenously 5 minutes before anesthesia induction.
干预措施: TEAS (Other)
Oxycodone
Bilateral Neiguan point (PC6), Zusanli point (ST36) and Sanyinjiao point (SP6) were selected. Stick electrodes only but do not stimulate; Oxycodone 0.1mg/kg was injected intravenously 5 minutes before anesthesia induction
干预措施: Oxycodone (Drug)
结局指标
主要结局
the VAS score of postoperative visceral pain
时间窗: 30 minutes after surgery、6 hours after surgery、24 hours after surgery、48 hours after surgery
the visual analogue scale of postoperative visceral pain,The basic method is to use a swimming scale about 10cm long, marked with 10 scales on one side, and "0" and "10" at each end, with 0 being painless and 10 being the most unbearable pain.
次要结局
未报告次要终点
研究者
Wang wanxia
Principal Investigator
Yangzhou University