Serum Opiorphin Level After Intraoperative Intravenous Lidocaine Infusion and Its Relation to Post-mastectomy Pain: a Prospective Double Blinded Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Serum Opiorphin level
研究概览
简要总结
A prospective, double blinded and randomized study included women with breast cancer and underwent mastectomy, and randomly allocated into two groups of equal size. Lidocaine group and control group.
详细描述
Women aged between 18 and 60 years old with breast cancer and underwent mastectomy, ASA I or II were included in the study.
- Group I (lidocaine): Patients were received intravenous 1 mg/kg of 2 % lidocaine as a loading dose (just before induction of anesthesia) then received 2mg/kg /h lidocaine as maintenance dose (with maximum of 200 mg/h) till the end of the operation (skin closure).
- Group II (control):- A standardized equal volume of intravenous bolus dose of normal saline was given as loading dose then normal saline was administered on an equal rate of infusion.
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
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged between 18 and 60 years old with breast cancer and underwent mastectomy, American society of Anesthesiologist I or II
排除标准
- •Patients with contralateral breast cancer, metastatic tumor, morbid obesity (BMI> 40), allergy to an amide local anesthetic, or morphine sulphate, heart block, renal, or liver dysfunction, or substance abuse disorder, or chronic opioid use
研究组 & 干预措施
Group I
Patients were received intravenous 1 mg/kg of 2 % lidocaine as a loading dose (just before induction of anesthesia) then received 2mg/kg /h lidocaine as maintenance dose (with maximum of 200 mg/h) till the end of the operation (skin closure).
干预措施: Lidocaine (Drug)
Group II
A standardized equal volume of intravenous bolus dose of normal saline was given as loading dose then normal saline was administered on an equal rate of infusion.
干预措施: Normal saline (Drug)
结局指标
主要结局
Serum Opiorphin level
时间窗: 24 hours postoperative
Measuring the opiorphin blood level
次要结局
- Visual analog pain score(24 hours postoperative)
研究者
Abdelrady S Ibrahim, MD
Assistant professor
Assiut University