The Analgesic Efficacy of Erector -Spinae Technique With Levobupvicaine in Patients Undergoing Upper Abdominal Cancer Surgery
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- morphine consumption
研究概览
简要总结
To study analgesic efficacy &safety of bilateral erector spinae block for upper abdominal cancer surgery as apart of multimodal analgesia.
详细描述
Patients will be randomly assigned using computer generated randomization program (http://www.randomizer.org) into two groups, each group of the them consist of 15 patients:
GROUP (A): {CONTROL GROUP} Patient will receive 20 ml of normal saline into interfascial plane between rhomboidus major &erector spinae muscle bilaterally at level thoracic spine T7,10 ml each side .
Group (B):
Patient will receive 20 mg 0.25% Levobupivacaine bilaterally as above 10 mg each side.
Preoperatively & post-operatively procedures:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient subjected to major upper abdominal cancer surgery.
- •The enrolled age will be from 18-70 years old.
- •ASA: I-III, NYHA: I-III.
排除标准
- •ASA & physical status (NYHA) > III.
- •Pregnant women.
- •Body mass index >40 kg/m
- •Pre-operative opioid consumption.
- •Contraindication or patient's refusal of the procedure.
- •Un co-operative patient.
- •Coagulopathy, skin infection, significant organ dysfunction or drug allergy.
研究组 & 干预措施
Group A
patients will receive 20 ml of normal saline into interfascial plane between rhomboids major &erector spinae muscle bilaterally at level thoracic spine T7,10 ml each side.
干预措施: Levobupivacaine (Drug)
Group B
Patients will receive 20 mg 0.25% Levobupivacaine into the interfascial plane between rhomboids major &erector spinae muscle bilaterally at level thoracic spine T7,10 ml each side.
干预措施: Levobupivacaine (Drug)
结局指标
主要结局
morphine consumption
时间窗: 24 hours
Decrease morphine consumption.
次要结局
- blood gas(24 hours)
- Hemodynamic(24 hours)
- VAS score(24 hours)
- patient satisfaction(24 hours)
研究者
Romany Gamal Rezk Bakeet
anesthesia specialist
South Egypt Cancer Institute