The Efficacy of Ultrasound-Guided Rhomboid Intercostal Block Versus Serratus Plane Block in Patients Undergoing Modified Radical Mastectomy: A Prospective Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- The total rescue morphine (mg) consumption in the first 24 post-operative hours.
研究概览
简要总结
The aim of this study is to evaluate analgesic efficacy of ultrasound-guided rhomboid plane block or serratus plane block versus Intravenous opioid in patients undergoing modified radical mastectomy.
详细描述
Breast cancer is the most frequently diagnosed malignancy and is the leading cause of cancer-related death among the female population.
Modified radical mastectomy (MRM) is the standard surgical treatment for cancer breast, which is usually associated with moderate to severe acute postoperative pain. Adequate postoperative pain relief is important to improve functional outcomes and to accelerate recovery and decrease hospital stay.
The postoperative pain may last >3 to 6 months after surgery and may proceed to chronic pain, with an incidence of 20% to 30%. Because chronic pain has many negative effects on patients, it may decrease the overall quality of life and may be a potential source of chronic opioid use. Therefore, preventing chronic pain is essential in these patients. In this regard, good acute postoperative pain management strategies have a very important role.
Regional anesthesia techniques can provide good postoperative pain management and may cause less incidence of chronic pain.
Many analgesic techniques have been proposed to relieve acute postoperative pain, including intercostal block, local anesthetic (LA) infiltration, block, paravertebral block, serratus plane block (SPB), and rhomboid intercostal block (RIB) to relieve acute postoperative pain
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
- Double (Participant, Investigator)
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
- •Scheduled for unilateral modified radical mastectomy.
- •Age 18-65 years
- •American Society of Anesthesiologists (ASA) physical status I- II
排除标准
- •Patient refusal
- •Coagulation disorders
- •Body mass index > 35 kg/m2
- •Uncooperative or psychiatric patients
- •Infection at the injection site
- •Patients with a history of allergy to local anesthetics
- •Patients with a history of treatment for chronic pain
- •Previous history of breast surgery or other chest surgery
结局指标
主要结局
The total rescue morphine (mg) consumption in the first 24 post-operative hours.
时间窗: 24 hours postoperative
Rescue analgesia in the form of 3 mg intravenous morphine (mg) will be given if the visual analog scale is ≥ 4 repeated with 10 minutes lockout interval till the visual analog scale becomes less than 3 guided with the occurrence of complications as nausea, vomiting, and respiratory depression.
次要结局
- Post-operative pain assessed by visual analog scale (VAS)(24 hours Postoperative)
- Heart rate(Intraoperative)
- Time to first rescue analgesic request (minutes)(24 hours Postoperative)
- Mean arterial blood pressure(Intraoperative)
- Adverse effects(intraoperative or 24 hours Postoperative)
- Intraoperative fentanyl consumption (µg).(Intraoperative)
研究者
Dina Hamdy Alhassanin
Resident of Anesthesia, Surgical Intensive Care and Pain Medicine
Tanta University