Comparison Between Effect of Systemic Fentanyl Infusion and Fentanyl Added as An Adjuvant to Lidocaine in Bier Block For Controlling Pain in Patients Undergoing Hand Surgeries
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 84
- 主要终点
- to compare intraoperative pain between systemic and local fentanyl using VAS score
研究概览
简要总结
Injury and deformity of the upper extremity can result in dysfunction to nerves, tendons and bones which can lead to disability and pain.
Various techniques of regional anesthesia are frequently used for upper extremity surgery. Specifically, intravenous regional anesthesia, the Bier block, is an effective anesthetic technique. This technique, developed by Dr August Bier in 1908, provides complete anesthesia, a bloodless field, and eliminates the need for general anesthesia. However, it was not until the 1960s that this technique was reintroduced and used in upper extremity surgery due to several disadvantages and reports of major complications. Because of the dose of lidocaine and tourniquet time, there is potential for cardiac and neurological complications such as arrhythmias, seizures, and compartment syndrome the aim of this study To evaluate the effect of Systemic Fentanyl Infusion compared to addition of Fentanyl as An Adjuvant to Lidocaine in Bier Block for Controlling Pain in Patients Undergoing Hand Surgeries
详细描述
Injury and deformity of the upper extremity can result in dysfunction to nerves, tendons and bones which can lead to disability and pain.
Various techniques of regional anesthesia are frequently used for upper extremity surgery. Specifically, intravenous regional anesthesia, the Bier block, is an effective anesthetic technique. This technique, developed by Dr August Bier in 1908, provides complete anesthesia, a bloodless field, and eliminates the need for general anesthesia. However, it was not until the 1960s that this technique was reintroduced and used in upper extremity surgery due to several disadvantages and reports of major complications. Because of the dose of lidocaine and tourniquet time, there is potential for cardiac and neurological complications such as arrhythmias, seizures, and compartment syndrome
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The patients will be randomly allocated to one of two groups; each group consisted of 42 patients. Randomization will be performed using a closed envelope method
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age from 18 years to 40 years
- •Patients of the American Society of Anesthesiologists (ASA) physical Status class I and II
- •BMI less than 40
排除标准
- •• Patients who refuse to participate in study.
- •Uncooperative patients.
- •Patient with crush injury
- •Peripheral vascular, neurological or muscle diseases.
- •Coagulation disorders that affect the blood's clotting activities e.g.: Hemophilia.
- •History of hypersensitivity to the drugs being evaluated
研究组 & 干预措施
group 1
patients will received lidocaine with dose 250 mg and fentanyl infusion in dose of 200 µg in rate 10ml /hr using 50ml syringe pump
干预措施: Fentanyl infusion (Drug)
group 2
patients will receive lidocaine 250 mg in addition to fentanyl injection in dose 100 µg by shots
干预措施: Fentanyl Injection (Drug)
结局指标
主要结局
to compare intraoperative pain between systemic and local fentanyl using VAS score
时间窗: baseline
pain will be assessed using an 11-point (0=no pain and 10=worst pain) VAS scale
次要结局
未报告次要终点
研究者
Abdelrahman Mostafa Ibrahim
resident doctor at Anaesthesia and ICU department
Assiut University