Ultrasound-guided Multilevel Erectorspinae Plane Block Versus Thoracic Epidural Analgesia for Prevention of Post Mastectomy Pain Syndrome for Breast Cancer Patients

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Erector spinae plane block (ESPB)
  Erector spinae plane block (ESPB) using multilevel injections of bupivacaine 0.25%. We will inject 15ml at the level of T2 and 15ml at the level of T5.
• Препарат 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.

Первичные конечные точки

• The average duration of analgesia [Срок оценки: 24 hours postoperatively]

Вторичные конечные точки (10)

• The total amount of morphine [Срок оценки: 24 hours postoperatively]
• Incidence of postmastectomy pain syndrome [Срок оценки: 6 months postoperatively]
• The total amount of fentanyl [Срок оценки: Intraoperatively]
• Heart rate (HR) [Срок оценки: 24 hours Postoperatively]
• Mean arterial blood pressure (MAP) [Срок оценки: 24 hours Postoperatively]
• Degree of pain [Срок оценки: 24 hours Postoperatively]
• Incidence of Postoperative nausea and vomiting (PONV). [Срок оценки: 24 hours Postoperatively]
• Complications related to the block [Срок оценки: 6 months postoperatively]
• Morphine-related complications [Срок оценки: 24 hours Postoperatively]
• Patient's satisfaction [Срок оценки: 24 hours Postoperatively]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• National Cancer Institute — Cairo

Идентификаторы

NCT: NCT06884852 · AP2405-201-046-193

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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