Ultrasound Guided Pectoral Nerve Block Using Bupivacaine Versus Bupivacaine and Dexmedetomidine as a Supplement to General Anesthesia in Modified Radical Mastectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Total intraoperative opioid consumption.
研究概览
简要总结
The incidence of breast cancer as well as the need for surgical treatment has increased.
Breast cancer surgery (BCS) is associated with many complications such as increased incidence of acute and chronic postoperative pain, postoperative nausea and vomiting (PONV), delayed hospital discharge.
Acute postoperative pain is an integral risk factor in the development of chronic pain after BCS.
Inadequate pain control can impact patient recovery including impaired pulmonary and immune function with an increased risk of ileus, thromboembolism, and myocardial infarction.
General anesthesia (GA) is the technique that commonly used for breast surgeries. The downside of GA includes inadequate pain control with high incidence of PONV . Also postoperative opioid for postoperative pain usually associated with many complications Regional anesthesia for breast surgery holds a great promise for breast cancer patients in terms of improved acute pain control with chronic pain prevention. It offers adequate analgesia while minimizing opioid consumption.
This study was designed in order to assess the efficacy and safety of PECS block as a supplement to GA in modified radical mastectomy (MRM) . Also to assess its role in decreasing the amount of opioid in the intra- and postoperative period after MRM. Also to assess its role in decreasing postoperative complications after BCS such as postoperative nausea and vomiting, delayed hospital discharge,and acute postoperative pain. Also to assess the role of dexmedetomidine in prolongation of the analgesic effect of PECS block.
详细描述
Breast cancer is the most frequent cancer among women; it causes the highest number of cancer-related deaths among them globally. The prognosis has improved considerably over the past 30 years, and the 5-year survival rate of patients has been increased due to the advances in the early detection and treatment of breast cancer.
Breast cancer surgery is associated with many complications such as increased incidence of acute and chronic postoperative pain, postoperative nausea and vomiting, delayed hospital discharge, and cancer recurrence. One of the most important complications is the occurrence of acute postoperative pain. Acute postoperative pain is an integral risk factor in the development of chronic pain after breast cancer surgery (BCS).
Inadequate pain control can impact patient recovery including impaired pulmonary and immune function with an increased risk of ileus, thromboembolism, and myocardial infarction. These factors can further increase the hospital length of stay, increase the healthcare costs, and decrease the patient satisfaction.
General anesthesia, including intravenous and inhalational agents, is the technique that commonly used for breast surgeries. The drawbacks of general anesthesia include inadequate pain control with high incidence of nausea and vomiting. Also the use of opioid and non-opioid analgesics for postoperative pain usually associated with many complications.
Regional anesthesia for breast surgery holds a great promise for breast cancer patients in terms of improved acute pain control with chronic pain prevention. It offers adequate analgesia while minimizing opioid consumption and its related side effects.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Hospitalized for modified radical mastectomy. American Society of Anesthesiologists (ASA), physical status II. Age between 21-65 year.
排除标准
- •Patient's refusal. Preexisting coagulopathy or anti-coagulant therapy. Local infection at site of injection. Pregnancy or breast feeding. Body Mass Index (BMI) > 35kg/m². Allergy to local anesthetics and drugs used. Prior breast surgery except for diagnostic biopsies.
结局指标
主要结局
Total intraoperative opioid consumption.
时间窗: During operation.
Total intraoperative fentanyl.
First time to rescue analgesia.
时间窗: First 24 hours after surgery.
Duration of postoperative analgesia.
Total postoperative opioid consumption.
时间窗: First 24 hours after surgery.
Total postoperative morphine consumption.
次要结局
- Hospital length of stay.(First 3 days after surgery.)
- Postoperative pain score.(0.3,6,9,12, and 24 hours after surgery.)
- Postoperative nausea &vomiting(First 24 hours after surgery.)
- Patients and surgeon satisfaction(First 24 hours after surgery.)
研究者
Thorya Mohammed Salem
Principal investigator
Zagazig University