The Impact of Intraperitoneal Spray Combined With Intravenous Lidocaine on Postoperative Pain After Myomectomy
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- General Hospital of Ningxia Medical University
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The incidence rate of moderate to severe pain within 24 hours
概览
简要总结
The purpose of this study is to determine whether laparoscopic spraying combined with intravenous injection of lidocaine can improve pain in patients undergoing laparoscopic myomectomy under general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- 否
入选标准
- •Age:18-65 years old;
- •ASA physical status classification I - III;
- •Undergoing laparoscopic hysteromyoma resection under general anesthesia;
- •The patient has been informed and has signed the informed consent form.
排除标准
- •Surgery duration exceeding 3 hours;
- •Need for additional surgery;
- •Allergy to the study drugs;
- •Presence of severe psychological,hepatic,renal,and cardiac diseases;
- •History of chronic pain or arrhythmia.
- •Elimination Criteria:
- •The patient or their family withdraws from or refuses to participate in the trial during the observation period;
- •Conversion from laparoscopy to laparotomy or change in surgical approach during the procedure.
研究组 & 干预措施
Group C(Control Group)
At the beginning of the operation, intravenous infusion of reifentanil 0.1~0.2μg/kg/min, propofol 2~4mg/kg/h, rocuronium 0.3mg/kg/h intermittently, inhalation of 1%~2% sevoflurane were maintained, the fluctuation of blood pressure was not more than 20% of the basic level, and the heart rate was 50~100 times /min. 10 minutes before the infusion proper amount of normal saline was administered to the patient. Subsequnetly, a continuous intravenous infusion proper amount of normal saline was maintained until the end of the sugery. Before closing the abdominal cavity, 20ml normal saline was administered.
干预措施: Saline (Drug)
Group IV(Intravenous injection of lidocaine Group)
At the beginning of the operation, intravenous infusion of reifentanil 0.1~0.2μg/kg/min, propofol 2~4mg/kg/h, rocuronium 0.3mg/kg/h intermittently, inhalation of 1%~2% sevoflurane were maintained, the fluctuation of blood pressure was not more than 20% of the basic level, and the heart rate was 50~100 times /min. 10 minutes before the infusion 2% lidocaine (1.5mg/kg) was administered to the patient. Subsequnetly, a continuous intravenous 2% lidocaine (2mg/kg/h) was maintained until the end of the sugery. Before closing the abdominal cavity, 20ml normal saline was administered.
干预措施: intravenous +saline lidocaine (Drug)
Group IP(Intraperitoneal spray of lidocaine Group)
At the beginning of the operation, intravenous infusion of reifentanil 0.1~0.2μg/kg/min, propofol 2~4mg/kg/h, rocuronium 0.3mg/kg/h intermittently, inhalation of 1%~2% sevoflurane were maintained, the fluctuation of blood pressure was not more than 20% of the basic level, and the heart rate was 50~100 times /min. 10 minutes before the infusion proper amount of normal saline was administered to the patient. Subsequnetly, a continuous intravenous infusion proper amount of normal saline was maintained until the end of the sugery. Before closing the abdominal cavity, 2% lidocaine (4-5mg/kg) + 1/200,000 epinephrine was spraged into the abdominal cavity.
干预措施: saline + intraperitoneal lidocaine (Drug)
Group IVPL(Intravenous and Intraperitoneal spray of lidocaine Group)
At the beginning of the operation, intravenous infusion of reifentanil 0.1~0.2μg/kg/min, propofol 2~4mg/kg/h, rocuronium 0.3mg/kg/h intermittently, inhalation of 1%~2% sevoflurane were maintained, the fluctuation of blood pressure was not more than 20% of the basic level, and the heart rate was 50~100 times /min. 10 minutes before the infusion 2% lidocaine (1.5mg/kg) was administered to the patient. Subsequnetly, a continuous intravenous infusion 2% lidocaine ( 2mg/kg/h) was maintained until the end of the sugery. Before closing the abdominal cavity, 2% lidocaine (4-5mg/kg) + 1/200,000 epinephrine was spraged into the abdominal cavity.
干预措施: intravenous + intraperitoneal lidocaine (Drug)
结局指标
主要结局
The incidence rate of moderate to severe pain within 24 hours
时间窗: Within 24 hours after surgery
Pain severity was measured using The NRS((Numerical Rating Scale),The NRS≥4 was considered moderate to severe pain. If the NRS score is greater than or equal to 4 at least once within 24 hours, it is considered moderate to severe pain.
次要结局
- NRS scores at different time intervals(2 hours, 4 hours, 8 hours, 12 hours, 24 hours after surgery)
- Sleep quality(Within 48h hours after surgery)
- Recovery quality(The first two days after surgery)
- The consumption of analgesic drugs.(Within 24 hours after surgery)
- The number of lidocaine adverse reactions, postoperative nausea and vomiting, and the use of vasoactive drugs.(During surgery and within 24 hours after surgery)
- BIS value(During the operation)
- The time for recovery of bowel function(After surgery)