Comparing the Perioperative Analgesic Effect of Two Different Volumes of Local Anesthetic Solution in Erector Spinae Plane Block in Patients Undergoing Modified Radical Mastectomy. A Randomized Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Total morphine consumption
研究概览
简要总结
Comparing the perioperative analgesic effect of two different volumes of local anesthetic solution in erector spinae plane block in patients undergoing modified radical mastectomy. A randomized comparative study.
详细描述
Breast cancer is the most common malignancy among females with incidence of about 2.1 million women each year. Modified Radical Mastectomy (MRM) is one of the main surgical treatments of breast cancer.
Pain can be severe enough to cause long-term disabilities and interfere with sleep and performance of daily activities . Multiple regional techniques have been developed in recent years for postoperative analgesia of breast surgery inkling erector spinae plane block (ESPB) aiming to be effective and associated with less complications when compared to the gold standard techniques (thoracic epidural analgesia or paravertebral block). Ultrasound guided erector spinae plane block (ESPB) was described in 2016 as a novel regional anesthetic technique for acute and chronic thoracic pain, it has been used as a regional anesthetic technique for breast surgery based on case reports and case series. It is a paraspinal fascial plane block that involves injection of local anesthetic deep in the erector spinae muscle and superficial to the tips of the thoracic transverse processes. The site of injection is distant from the pleura, major blood vessels, and spinal cord.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 60 years.
- •Genders eligible for study: female sex.
- •American Society of Anesthesiologists (ASA) I-II.
- •Undergoing modified radical mastectomy.
- •Body mass index (BMI) from 18.5 to 30 kg.
排除标准
- •Patient refusal.
- •Known allergy to local anesthetics .
- •Bleeding disorders; platelets count <50,000 ,prothrombin concentration < 60% or any coagulopathy disorder.
- •Use of any anti-coagulants .
- •Inability to provide informed consent.
- •Neurological disorders.
- •Patient with psychiatric disorders.
研究组 & 干预措施
Erector Spinae Plane block (high concentration-low volume)
Patients will preoperatively receive high concentration-low volume ultrasound guided Erector Spinae Plane block, and then the patient will be transferred to the operating room (one syringe of 15 ml bupivacaine 0.5% {15 ml bupivacaine 0.5% }, for each patient).
干预措施: Erector spinae plane block(15 ml bupivacaine 0.5%) (Drug)
Erector Spinae Plane block (low concentration-high volume)
Patients will preoperatively receive low concentration-high volume ultrasound guided Erector Spinae Plane block, and then the patient will be transferred to the operating room ) one syringe of 30ml bupivacaine 0.25% {15 ml bupivacaine 0.5% and 15ml normal saline}, for each patient.
干预措施: Erector spinae plane block (15 ml bupivacaine 0.5% and 15ml normal saline) (Drug)
结局指标
主要结局
Total morphine consumption
时间窗: 24 hours postoperative
Rescue analgesia will be provided in the form of intravenous morphine 3 mg boluses if the patient indicates visual analogue scale ≥ 4. The total amount of morphine given in 24 hours will be recorded for the two groups. A maximum dose of 0.5 mg/kg/24hours of morphine is allowed. Visual Analogue Scale (VAS) (0 represents "no pain" while 10 represents "the worst pain imaginable").
次要结局
- Time 1st rescue analgesia(24 hours postoperative)
- Pain score(24 hours postoperative)
研究者
Yasmina Sayed
Assistant lecturer of anesthesiology and surgical ICU and pain management
Cairo University