Erector Spinae Plane Block Versus Subcostal Transversus Abdominis Plane Block in Patients Undergoing Open Liver Resection Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- total morphine requirement in the first 24 hours
研究概览
简要总结
Liver resection surgery is a common surgical procedure which is performed on patients with benign, malignant or metastatic hepatic tumor as well as for living liver donor. Liver resection surgery is usually performed through either right subcostal or inversed L-shaped incision; both approaches are associated with a significant postoperative pain which requires intensive analgesic plan to facilitate early mobilization and minimize complications.
There are various lines for pain management in liver resection surgery such as systemic analgesic drugs, neuraxial blocks (e.g., thoracic epidural analgesia) and transversus abdominis plane [TAP] block).
Systemic analgesic drugs are nearly constantly used in liver resection. However, being systemically administered, these drugs have many side effects on many organs and cannot totally eliminate postoperative pain. Thoracic epidural block is commonly associated with hypotension; furthermore, its use has other limitations such as delaying postoperative mobilization and possible hematoma and cord compression in patients with coagulopathy which is expected following liver resection. Therefore, there had been an increased interest in the use of abdominal field blocks to avoid disadvantages of neuraxial blocks and minimize the use of parenteral analgesic drugs.
TAP block is one of the classic field blocks which is extensively used in laparotomies including liver resection. However, the lack of visceral pain control TAP block influences the quality of its analgesic effect in this type of patients. Nevertheless, TAP block, namely the subcostal approach, is still the recommended field block in the latest procedure-specific recommendations for pain management in liver resection as it is the only block which showed good evidence.
In recent years, there has been increased interest in a newer field block, the erector spinae plane block (ESPB), due its easy performance and the possible coverage of visceral pain in addition to the somatic pain. ESPB showed promising results in liver resection surgery. ESBP was superior to TAP block in various abdominal surgeries. However, its analgesic efficacy had not been previously compared in relation to TAP in patients undergoing open liver resection surgery.
详细描述
An independent research assistant will be responsible for opening the envelope and drug preparation with no further involvement in the study. The local anesthetic solution preparation will be as follow; 2 syringes of 20 ml of 0.25% isobaric bupivacaine.
Upon arrival to the operating room, routine monitors (electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and pre-medication drugs will be delivered (metoclopramide 10 mg, and omeprazole 40 mg).
General anesthesia will be induced by 2-3 mg/kg propofol and 1-2 mcg/kg fentanyl. Tracheal intubation by direct laryngoscopy will be facilitated by atracurium 0.5 mg/kg. Anesthesia will be maintained by 2-2.5% sevoflurane and 0.1 mg/kg/20min atracurium.
After induction of anesthesia, patients will receive their assigned intervention.
Intraoperative analgesic management Morphine boluses (titrated 0.05 mg/kg boluses till response) will be given in case of inadequate analgesia (heart rate/mean blood pressure increase by 20% from the baseline) Intraoperative fluid and hemodynamic management will be according to the discretion of the attending anesthetist.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients (>18 years),
- •ASA-physical status I-III
- •undergoing open liver resection surgery for either primary/metastatic hepatic malignancy, biliary tract malignancy, or benign hepatic tumor
排除标准
- •history of allergy to any of the study drugs,
- •a body mass index (BMI) <18 or ≥ 35 kg/m2,
- •coagulopathy (INR >1.5 and/or platelet count <70000/µL),
- •local infection,
- •history of chronic pain or regular opioid use;
- •inability to comprehend the Numeric Rating Scale (NRS),
- •liver resection combined with a second surgical procedure, laparoscopic resections,
- •pregnant or lactating women.
- •Patients with complicated procedures
- •those needing postoperative ventilation will be excluded from the study
研究组 & 干预措施
subcostal transversus abdominis plane block group
subcostal transversus abdominis plane block
干预措施: subcostal transversus plane block (Other)
erector spinae plane block group
erector spinae plane block
干预措施: erector spinae plane block (Other)
结局指标
主要结局
total morphine requirement in the first 24 hours
时间窗: 0.5 hour after extubation till 24 hour after extubation
mg
次要结局
- time to first morphine requirement(1 minute after block administration till 24 hours postoperatively)
- intraoperative morphine requirement(15 minutes after block administration till 1 minutes after extubation)
- heart rate(15 minutes before induction of anesthesia, 15 minutes after induction of anesthesia, every 15 minutes intraoperatively and 0.5, 1, 2, 4, 6, 18, 24 hours postoperatively)
- mean arterial pressure(15 minutes before induction of anesthesia, 15 minutes after induction of anesthesia, every 15 minutes intraoperatively and 0.5, 1, 2, 4, 6, 18, 24 hours postoperatively)
- NRS(0.5, 1, 2, 4, 6, 18, 24 hours after leaving the operating room)
- Time to independent movement(0.5 hour after extubation till 24 hour after extubation)
- Modified Ramsay Sedation Score(0.5, 1, 2, 4, 6, 18, 24 hours after leaving the operating room)
研究者
Maha Mostafa Ahmad, MD
Principal Investigator
Kasr El Aini Hospital