Effect of Noise Isolation During General Anesthesia on the Incidence of Moderate to Severe Postoperative Pain in Patients Undergoing Major Abdominal Surgery
概览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- The incidence of moderate to severe postoperative pain
概览
简要总结
To investigate the effect of noise isolation during general anesthesia on the incidence of moderate to severe postoperative pain in patients undergoing major abdominal surgery. The aim of this study was to determine whether noise isolation can reduce the Incidence of moderate to severe postoperative pain and analgesic use.
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)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 18 and 70, both male and female.
- •American Society of Anesthesiologists Classification 1-3
- •Patients undergoing elective major abdominal surgery under general anesthesia(Surgery time ≥ 2h)
- •Voluntarily accept patient controlled intravenous analgesia and signed informed consent
排除标准
- •Patients with previous severe disease
- •Patients with hearing abnormalities
- •Patients requiring mechanical ventilation or undergoing epidural catheters or other types of regional anesthesia after surgery
- •Patients with chronic preoperative pain and/or long-term analgesic use
- •Patients who could not cooperate with the study for any reason
研究组 & 干预措施
Noise-canceling Group
Intraoperative intervention with noise-canceling earphones was performed to isolate the noise
干预措施: Wear noise-cancelling earphones (Device)
Control Group
After general anesthesia, the intervention of wearing noise-canceling earphones was not given
结局指标
主要结局
The incidence of moderate to severe postoperative pain
时间窗: From ending of the surgery to 24 hours postoperatively
Moderate to severe postoperative pain：NRS score ≥ 4 (Pain was assessed using NRS scale of 0-10, with 0 being no pain and 10 being most painful)
次要结局
- Maximum pain score (NRS score) at 0-48 hours postoperatively(From ending of the surgery to 48 hours postoperatively)
- Patient controlled analgesia pump analgesic consumption(From the time when the surgery was completed until to 48 hours after surgery)
- Accumulative postoperative pain NRS(From ending of the surgery to 48 hours postoperatively)
- The incidence of additional analgesic requirements(From the time when the surgery was completed until to 48 hours after surgery)
- The incidence of moderate to severe postoperative pain(From ending of the surgery to 48 hours postoperatively)
- Patient controlled analgesia pump analgesic consumption(From the time when the surgery was completed until to 24 hours after surgery)