Ultrasound-guided Multilevel Erectorspinae Plane Block Versus Thoracic Epidural Analgesia for Prevention of Post Mastectomy Pain Syndrome for Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- The average duration of analgesia
研究概览
简要总结
The aim of this study is to compare the analgesic efficacy of multilevel erector spinae plane block (ESPB) vs thoracic epidural in modified radical mastectomy (MRM) regarding duration of analgesia, postoperative opioid consumption, effect on intraoperative fentanyl consumption, postoperative numerical pain rating scale and quality of life for the next 6 months.
详细描述
Breast cancer is the most common malignancy among females. Modified Radical Mastectomy (MRM) is the principal surgical treatment for breast cancer. The standard mode of anesthesia is general anesthesia, in addition to regional blocks for effective postoperative pain control.
Pain is usually managed by narcotics, which have many side effects, including prolonged sedation, increasing incidence of pain recurrence, respiratory depression, nausea & vomiting and paralytic ileus. All requiring close monitoring and in some occasions Intensive Care Unit (ICU) admission. Thoracic epidural and paravertebral blocks are the gold standard techniques. However, both techniques may lead to some serious complications including spinal cord injury, pneumothorax, incompatibility with pre-existing anticoagulation or antiplatelet therapy and hemodynamic instability.
Recently, multiple regional techniques have been used for postoperative thoracic pain control, including that caused by modified radical mastectomy. Interfascial plane blocks are currently the hot topic in management of postoperative pain. One of these blocks is erector spinae plane block (ESPB). It is an interfacial Para spinal plane block that is simple, safe, effective and associated with fewer complications in comparison to the gold standard techniques.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients age ≥ 18 years and ≤ 65 Years.
- •Type of surgery; Modified Radical Mastectomy (MRM)
- •Physical status ASA II, III.
- •Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.
排除标准
- •Patient refusal.
- •Allergy or a contraindication to the drug used in the study, e.g. local anesthetics, opioids.
- •History of psychological disorders.
- •History of chronic pain.
- •Contraindication to regional anesthesia e.g. sepsis, peripheral neuropathies and coagulopathy.
- •Advanced chronic renal disease, which is defined as a chronic kidney disease (CKD) in which there is a severe reduction in glomerular filtration rate (GFR < 30 ml/min) and includes stages 4 and 5 of the CKD classification.
- •Decompensated cirrhosis, which is defined as an acute deterioration in liver function in a patient with cirrhosis and is characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage.
- •Severe heart disease which is defined as NYHA class iii (moderate symptoms with less than normal activity, marked limitation of function status) or NYHA class IV (severe symptoms with features of heart failure with minimal activity or at rest and severe limitation of functional status)
- •Severe lung disease which includes oxygen saturation of blood less than 92%, RR more than 20, FEV1/FVC ratio less than 60%.
- •Pregnancy.
研究组 & 干预措施
Erector spinae plane block (ESPB)
Erector spinae plane block (ESPB) using multilevel injections of bupivacaine 0.25%.
We injected 15ml at the level of T2 and 15ml at the level of T5.
干预措施: Erector spinae plane block (ESPB) (Drug)
Thoracic epidural block
Thoracic epidural block at level of T5 -T6 using 10 ml of bupivacaine 0.25% as a bolus followed by 5 ml bupivacaine 0.25% every 1-2 hours depending on the duration of surgery and the response of the patient.
干预措施: Thoracic epidural block (Drug)
结局指标
主要结局
The average duration of analgesia
时间窗: 24 hours postoperatively
The average duration of analgesia will be recorded from the end of surgery till the first dose of morphine administrated.
次要结局
- The total amount of morphine(24 hours postoperatively)
- Incidence of postmastectomy pain syndrome(6 months postoperatively)
- The total amount of fentanyl(Intraoperatively)
- Heart rate (HR)(24 hours Postoperatively)
- Mean arterial blood pressure (MAP)(24 hours Postoperatively)
- Degree of pain(24 hours Postoperatively)
- Incidence of Postoperative nausea and vomiting (PONV).(24 hours Postoperatively)
- Complications related to the block(6 months postoperatively)
- Morphine-related complications(24 hours Postoperatively)
- Patient's satisfaction(24 hours Postoperatively)
研究者
Dr Ahmed elsayeh
Assistant Lecturer of Anesthesiology, Surgical Intensive Care Unit and Pain Medicine, National Cancer Institute ,Cairo University, Egypt
National Cancer Institute, Egypt