Impact of Thoracic Epidural Infusion Versus Continuous Serratus Anterior Plane Block Versus Continuous Erector Spinae Plane Block on Incidence of Post Thoracotomy Pain Syndrome: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 111
- 主要终点
- Incidence of patients developing post-thoracotomy pain syndrome
研究概览
简要总结
The aim of this study is to evaluate the impact of Ultrasound-guided Erector Spinae plane block compared to Ultrasound-guided serratus anterior plane block on the emergence of post-thoracotomy pain syndrome in patients undergoing lobectomy for lung cancer.
详细描述
Lung cancer has the highest incidence of all malignancies worldwide and accounts for approximately 13% of all cancer cases. Lung cancer is still the most common cause of cancer-related deaths, and lung resection surgeries could be the main therapeutic option. Hence, the number of thoracotomy procedures is progressively increasing as is the incidence of post-thoracotomy pain. In addition to amputation and mastectomy, thoracotomy is considered the main etiology of severe and long-term acute and chronic post-surgical pain syndromes (CPSPs). The prevalence of post-thoracotomy pain syndrome (PTPS) is widely variable (30%-50%) and may range from 11% to 80%, according to other studies.
The International Association for the Study of Pain (IASP) has defined post-thoracotomy pain syndrome as "pain that recurs or persists along the thoracotomy scar at least 2 months after the procedure". In addition, post-thoracotomy pain syndrome is mostly described with neuropathic manifestations along the thoracotomy scar and in the mammary, inframammary, ipsilateral scapular and interscapular areas.
The ultrasound-guided erector spinae plane (ESP) block is a novel technique for thoracic analgesia that promises to be a relatively simple and safe alternative to more complex and invasive techniques of neural blockade.
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
- Single (Outcomes Assessor)
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
- •Age (18-65) Years
- •Physical status American Society of Anesthesiologists Classification II, III
- •Patients undergoing lobectomy through lateral thoracotomy
- •Body mass index (BMI): (20-40) kg/m2
排除标准
- •Patient refusal.
- •Age <18 years or >65 years
- •Body mass index (BMI) <20 kg/m2 and >40 kg/m2
- •Known sensitivity or contraindication to drugs used in the study
- •Contraindication to regional anesthesia e.g. local infection at site of introduction, pre-existing peripheral neuropathies and coagulopathy.
- •Pregnancy.
- •Physical status American Society of Anesthesiologists Classification IV
- •patients on chronic analgesic therapy (daily morphine ≥30 mg or equivalent dose of other opioids or tramadol or any medication for neuropathic pain)
- •patients with a history of drug abuse
- •patients with neuropsychiatric diseases; patients with a history of chronic pain syndromes that may enhance sensitivity to pain, for example, fibromyalgia
- •patients with a history of thoracic surgery through lateral thoracotomy; and patients with recurrent chest malignancies within 3 months.
- •All patients who developed severe intra- or post-operative bleeding or required postoperative mechanical ventilation were also excluded from the study.
- •Thoracic spine disorders or deformity.
结局指标
主要结局
Incidence of patients developing post-thoracotomy pain syndrome
时间窗: 12 weeks postoperatively
The incidence of patients developing post-thoracotomy pain syndrome according to grading system for neuropathic pain (GSNP
次要结局
- Morphine consumption(48 hours Postoperatively)
- Fentanyl consumption(Intraoperatively)
- Post-thoracotomy pain syndrome severity(12 weeks postoperatively)
- Patient's Quality of life(12 weeks postoperatively)
- Postoperative Patient's activity level(12 weeks postoperatively)
- Heart rate(Intraoperatively)
- Mean arterial blood pressure(Intraoperatively)
- Nausea and vomiting(24 hours postopertivley)
- Post-operative pain(24 hours postopratively)
- Time taken till 1st rescue analgesic request(24 hours postopratively)
- Postoperative pulmonary complications(24 hours postopratively)
研究者
Ahmed Shaban Mohammed
assisstant lecturer
National Cancer Institute, Egypt