Application of Opioid-sparing Multimodal Anesthesia Based on Rectus Sheath Block in Open Upper Abdominal Surgery:A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Tumor recurrence rate
研究概览
简要总结
General anesthesia combined subcostal transversus abdominis plane (TAP)or rectus sheath block (RSB)can significantly reduce the use of opiates in minimally invasive surgery.However, similar reduction was not observed in open abdominal surgery during perioperative period.Therefore, the investigators should try to improve the blocking methods to reduce the side effects of a large number of opiates. Based on the range and its analgesic effect of various nerve block is obviously related to the injection site of local anesthetics, this randomized controlled study hypothesized that modified RSB under the guidance of surgical incision may be more effective in inhibiting the harmful stimulation of surgery.
详细描述
For abdominal cancer surgery with midline incision, subcostal transversus abdominis plane or rectus sheath block combined with general anesthesia was more effective in reducing pain scores and opioid consumption compared with general anesthesia alone. However, there was no statistically significant difference in supplementary fentanyl during operation. Besides adequate pain relief around incisions, blunting visceral traction response has also an important role in hemodynamic stability.With the evidences for a potential mechanism for the antinociceptive effects of propofol on visceral nociception and dexmedetomidine combined with oxycodone can provide good visceral analgesia, the investigators supposed that visceral nociception was well suppressed by adequate antinociceptive drugs. The propofol combination with dexmedetomidine may had significant effect on the reduction of the sympathoadrenergic tone with decrease of blood pressure and heart rate.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-85 years
- •Anesthesiologists (ASA) risk classification I to IV
- •Scheduled to undergo midline incision of upper abdomen (From xiphoid to navel )
排除标准
- •Patient refusal
- •Any contraindications to regional techniques (allergy to local anesthetics, infection around the site of the block, and coagulation disorder)
- •History of analgesics dependence
- •Any difficulty with communication
- •Allergy to the study drugs
- •Heat rate < 50 beats/minutes or II-III Atrioventricular block
- •Previous open surgery
- •Previous definite history of malignant tumor
- •Who had an estimated intraoperative blood loss of more than 500 mL
结局指标
主要结局
Tumor recurrence rate
时间窗: 1-year after surgery
Tumor recurrence rate after surgery
Opiate consumption
时间窗: From the beginning to the end of anesthesia,up to 6 hours.
Remifentanil consumption
次要结局
- The occurrence of cardiovascular or cerebrovascular events(From the end of surgery to the time the patients discharge, up to 1 month.)
- Opiate consumption(From the end of anesthesia to 48 hours after surgery, up to 2 days.)
- Pain scores(48 hours after surgery)
- Time for first to press pump(Up to 2 days after surgery)
- Length of hospital stay(From the end of surgery to the time the patients discharge, up to 1 month.)
- Mortality(1-year after surgery)
- Concentration of epinephrine(Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.)
- Time of anal exsufflation(Up to 7 days after surgery)
- Delirium(Up to 7 days after surgery)
- The occurrence of nausea and vomiting(Up to 7 days after surgery)
- Concentration of norepinephrine(Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.)
- Concentration of tumor necrosis factor-α(Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.)
- Concentration of interleukin-6(Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.)
- Concentration of cortisol(Time before anesthesia induction,immediately after incision,celiac exploration and immediately after closing the abdominal cavity.)