Ultrasound Guided Erector Spinae Plane Block in Breast Cancer Surgery: Analgesia, Spread and Immunomodulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Analgesic efficacy of ESPB
研究概览
简要总结
Prospective interventional study
详细描述
The aim of the present study is to evaluate the effect of US guided unilateral ESPB using different volumes of local anaesthetics on analgesic efficacy, dermatomal spread and immunomodulation in breast cancer surgery.
The primary outcome is the analgesic efficacy of the different local anaesthetic volumes of ESPB.
The secondary outcomes are the dermatomal dye spread and sensory coverage, immunomodulation and complications in breast cancer surgery.
Immunomodulation will be assessed by measuring Natural killer cells cytotoxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status 1 or 2 scheduled for mastectomy under the effect of General Anaesthesia
排除标准
- •Patient refusal.
- •Allergy or contraindication to any of the studied medications or anaesthetic agents.
- •Chronic opioid analgesic use.
- •Morbid obesity (BMI ≥ 40 kg/m2).
- •Scoliosis or any vertebral anomalies or previous spinal surgeries.
- •Infection at the site of injection or any other contraindication for regional anaesthesia.
- •Duration of surgery more than 90 minutes.
- •Renal impairment.
结局指标
主要结局
Analgesic efficacy of ESPB
时间窗: Up to 24 postoperative hours
Analgesic efficacy of Erector Spinae plabe block by measuring visual analogue scale which ranges from 0 to 10. 0 indicates no pain and 10 indicates maximum imaginable pain
次要结局
- Spread of the injected dye in Erector Spinae plane(Patients will be imaged 15 minutes after the block and before induction of general anaesthesia and surgery.)
- Dermatomal sensory coverage of ESPB(Assessment will be done bilaterally every 3 minutes for 15 minutes after ESPB.)
研究者
Ahmed Mohamed Mohamed Rabah Abdella
Principal investigator
Alexandria University