Efficacy of Perioperative US-Guided Serratus Anterior Plane Block Versus Thoracic Epidural in Adult Patient Undergoing Thoracotomy: A Randomized Comparative Double-Blinded Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Postoperative total morphine requirement.
研究概览
简要总结
Thoracic surgeries is known to be one of the most painful surgeries . Multiple analgesic techniques have been used for post operative analgesia including Thoracic epidural , Patient Controlled Analgesia and systemic opioids. Opioids are associated with multiple sied effects including : PONV , Respiratory depression and ileus while thoracic epidural has its own complications such as hemodynamic instability , injury of spinal cord, pneumothorax and epidural hematoma.
Peripheral nerve blocks provide good alternative for perioperative analgesia. The purpose of our study is to compare the effectiveness of perioperative continuous serratus anterior plane block versus continuous thoracic epidural in pain management during thoracic surgeries for malignancy resection.
详细描述
Thoracic surgeries is known to be one of the most painful surgeries and it is considered the major factor to the morbidity and mortality postoperatively. A variety of analgesic techniques for example; systemic opioid, intercostal nerve blockade, intra-pleural analgesia, an epidural opioid with or without local anesthetic, and patient-controlled analgesia (PCA) via systemic or epidural route has been used very commonly for thoracotomy pain management.The use of systemic opioids alone was associated with a 23.4% incidence of post-thoracotomy pain syndrome. Also, high doses of opioids represent a safety concern due to respiratory depression. The high incidence of postoperative nausea and vomiting (PONV) exacerbates patients' discomfort. Long-acting opioids hinder faster recovery, thereby delaying discharge. , Serratus anterior plane block (SAPB) has been recently introduced as a promising method that can be used between T2 and T9 levels for analgesia in thoracic surgery. SAPB seems to provide its effect through blockade of the lateral cutaneous branches of the intercostal nerves. Previous reports showed that after superficial SAPB the duration of sensory block was between 7 and 12 hrs. Continuous SAPB could represent an important analgesic alternative in patients who have contraindications to thoracic epidural for example patients with coagulopathies. Hence it is important to thoroughly study this block as an analgesic modality in thoracotomies. Moreover, episodes of hypotension during thoracotomies as during vascular clamping are challenging in the presence of thoracic epidural.
The purpose of our study is to compare the effectiveness of perioperative continuous serratus anterior plane block versus continuous thoracic epidural in pain management during thoracic surgeries for malignancy resection. To the best of our knowledge controlled randomized, prospective studies about the use of this technique in thoracotomies for resection of malignancies are lacking and none has been published to discuss this issue. Also, studies reporting patients' satisfaction are lacking.
Aim of the work
This study aims at evaluating the efficacy of applying continuous serratus anterior plane block (SAPB)as a perioperative analgesic modality for thoracic cancer surgeries (mesothelioma and bronchogenic carcinoma) as compared to continuous thoracic epidural as reflected on decreasing perioperative opioids consumption and postoperative VAS.
Hypothesis
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physical status ASA II and III.
- •Body mass index (BMI): > 20 kg/m2 and < 40 kg/m
- •A patient undergoing thoracotomy for cancer surgery (Lobectomy, Pneumonectomy, and Decortication).
排除标准
- •Patient refusal
- •Known sensitivity or contraindication to local anesthetics.
- •History of psychological disorders.
- •Localized infection at the site of block.
- •Coagulopathies with a platelet count below 50,000 or an INR>1.5: hereditary (e.g. hemophilia, fibrinogen abnormalities & deficiency of factor II) - acquired (e.g. impaired liver functions with PC less than 60 %, vitamin K deficiency &therapeutic anticoagulants drugs),History of unexplained or easy bruising and Prolonged bleeding from small cuts or after dental procedures.
- •patients need prolonged mechanical ventilation postoperatively excluded from our study.
- •failed blocks will be excluded from our study
研究组 & 干预措施
Serratus anterior plane block:
干预措施: Continuous Serratus anterior plane block (Procedure)
Serratus anterior plane block:
干预措施: Bupivacaine (Drug)
Thoracic Epidural
干预措施: Thoracic Epidural (Procedure)
Thoracic Epidural
干预措施: Bupivacaine (Drug)
Thoracic Epidural
干预措施: lidocaine with epinephrine (Drug)
结局指标
主要结局
Postoperative total morphine requirement.
时间窗: 24 hours
Postoperative total morphine requirement.
次要结局
- Time to the first analgesia requested by the patient.(24 hours)
- Patient satisfactory score(24 hours)
- Postoperative pain(24 hours)
- Intraoperative fentanyl requirement.(300 minutes)
- Length of hospital stay.(2 weeks)
