Effect of Transversus Abdominis Plane Block Combined With General Anesthesia on Perioperative Stress Response in Patients Undergoing Radical Gastrectomy: A Double-blind Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Physiological Parameters: Plasma Concentration of Epinephrine (E)
研究概览
简要总结
This study evaluates the effect of transversus abdominis plane(TAP) block combined with general anesthesia on perioperative stress response in patients undergoing radical gastrectomy. One third of participants will receive TAP block combined with general anesthesia, another one third of participants will receive epidural anesthesia combined with general anesthesia, while the rest will receive only general anesthesia.
详细描述
Clinically, combining epidural with general anaesthesia may confer many advantages to patients undergoing major thoracic, abdominal or orthopaedic surgery. Epidural anaesthesia can attenuate sympathetic hyperactivity and the stress response, maintain bowel peristalsis, spare the use of opioids, and facilitate postoperative feeding and physiotherapy. However, establishing epidural anesthesia is not without risks and contraindications, including refusal by the patient, technical failure, unintentional dural puncture, waist and back pain and local anaesthetic toxicity. When neurologic complications do occur, the resulting morbidity and mortality is considerable. Transversus abdominis plane (TAP) block, is another new regional anesthesia technique, has been introduced as an abdominal wall block capable of providing effective analgesia, reducing opioid consumption, and lessening opioid-related side effects. In addition,TAP block, somewhat as a pre-emptive analgesia approach, is a way of pain intervention before noxious stimulation which has been reported to be potent to attenuate the stress response. Although the analgesia efficiency of TAP block has been widely studied, its effectiveness to suppress stress response has little comparison with classic epidural block and general anesthesia. Unlike epidural anaesthesia, TAP block is easy to administer and lower incidence for side-effects.The investigators hypothesize that the TAP block reduces the stress response of surgery to the similar extent to epidural anaesthesia when combined with a standard general anaesthesia for abdominal surgery.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No contraindication to epidural or ropivacaine
- •First time surgery for current conditions
- •Not on chronic pain medications or sedative
排除标准
- •The subject has a known or suspected allergy to opioid analgesics or ropivacaine
- •Emergency patients
- •The subject has know central nervous system disease or neurological impairment
- •The subject has preoperative infection, and a history of immune and endocrine system disease, chemotherapy, or blood transfusion.
研究组 & 干预措施
Transversus abdominis plane block
The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.
干预措施: Transversus abdominis plane block (Other)
Epidural anesthesia
The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
干预措施: Epidural anesthesia (Other)
Control
The Control group receives standard IV-inhaled general anesthesia.
干预措施: control (Other)
结局指标
主要结局
Physiological Parameters: Plasma Concentration of Epinephrine (E)
时间窗: up to 48h after surgery
Venous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The E levels are measured by ELISA kits.
Physiological Parameters: Plasma Concentration of Cortisol (Cor)
时间窗: up to 48h after surgery
Venous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The Cor levels are measured by ELISA kits.
Hemodynamic Parameters: Heart Rate.
时间窗: up to 48h after surgery
Continuous monitoring of heart rate to 48 hours after surgery.
Physiological Parameters: Plasma Concentration of Norepinephrine (NE)
时间窗: up to 48h after surgery
Venous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The NE levels are measured by ELISA kits.
Physiological Parameters: Plasma Concentration of Glucose (Glu)
时间窗: up to 48h after surgery
When venous blood are collected, glucose levels are measured immediately by Glucometer.
Hemodynamic Parameters: Mean Arterial Pressure(MAP)
时间窗: up to 48h after surgery
Continuous monitoring of mean arterial pressure(MAP) to 48 hours after surgery. mean arterial pressure(MAP)＝ (systolic blood pressure＋2×diastolic blood pressure)/3
次要结局
- Side Effects: Number of Participants With Sedation(up to 48h after surgery)
- Side Effects: Number of Participants With Vomiting(up to 48h after surgery)
- Anesthetics Consumption: Sufentanil Consumption(during operation)
- Questionnaire: Pain Scores on Movement(1hr, 6hr, 12hr, 24hr, and 48hr after surgery)
- Side Effects: Number of Participants With Nausea(up to 48h after surgery)
- Anesthesia Recovery: the Time of First Flatus(Through study completion, an average of 2 weeks)
- Questionnaire: Pain Scores at Rest(1hr, 6hr, 12hr, 24hr, and 48hr after surgery)
- Anesthesia Recovery: Number of Participants With Prolonged Hospitalization(Through study completion, an average of 2 weeks)
研究者
Zhao Guoqing
Clinical Professor
Jilin University