Analgesic Efficacy of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Erector Spinae Block for Acute Pain Management in Modified Radical Mastectomy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- analgesia request
研究概览
简要总结
To evaluate the analgesic efficacy of magnesium sulphate as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy surgery for acute pain management
详细描述
The participating female will be randomly allocated using computer generated randomization program (http://www.randoiler.org) into one of 2 groups.
Group (C) / (I):20 patients (control group):
Patient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5.
Group (M) / (III): 20 patients (magnesium slphate group):
Patient will receive 20ml 0.25% levobupivacaine above + 0.7 mg/kg MgSo4. The patient, the anesthesiologist who administered the drugs and the data collector will be blinded to the study drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patient
- •American society of anesthesiologists (ASA) I and II physical status
- •age from 25 to 70 years old
- •scheduled for either left or right modified radical mastectomy (MRM)
排除标准
- •infection of the skin at or near site of needle puncture
- •coagulopathy,
- •drug hypersensitivity or allergy to the studied drugs,
- •central or peripheral neuropathy,
- •significant organ dysfunction cardiac dysrrhythmias,
- •obesity (BMI>35kg/m2)
- •recently use analgesic drugs
结局指标
主要结局
analgesia request
时间窗: 24 hours
first request for analgesia .
次要结局
未报告次要终点
研究者
Peter Rafaat Edward Iskander
principal investigator
South Egypt Cancer Institute