Comparison of Intravenous Regional Anesthesia ( Bier's Block) and Systemic Analgesia for Upper Extremity Procedures in the Emergency Department of Al-Zahra University Hospital
试验速览
- 阶段
- 2 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- pain score
研究概览
简要总结
Background: There are three methods for procedural sedation in upper extremity traumas; systemic, regional and local anesthesia. There is controversy in the literature regarding the method of choice for this purpose.
Objectives: The aim of this study was to compare conscious sedation and Bier's block methods for pain reduction in upper extremity trauma patients.
Patients and Methods: This was a randomized clinical trial. Patients were randomly allocated to either the Bier's block or the conscious sedation group. Pain reduction was assessed by a numerical rating scale; patients, surgeons and physicians responsible for analgesia satisfaction were assessed using a five-point Likert scale.
In this study, we aimed to compare the effectiveness, complications, duration, hemodynamic stability and patient and physician satisfaction between systemic analgesia and Bier's block method performed at the emergency department.
详细描述
Patients and Methods
Study Design
This is a randomized clinical trial to be conducted at two tertiary health care centers, with census of 102000 and 60000 visits per year, during years 2017 and 2018. The study design has been approved by ethics committee of the university. Informed consents will be obtained from patients. And patients who refuse to participate in the study are excluded from the study and will receive analgesia based on the physician responsible for analgesia preference.
Population
All adult patients (aged 18 or more) with upper extremity trauma who need procedural analgesia in the ED are included in this study. Patients with a history of seizure, known allergy to analgesic substances, sickle cell anemia, peripheral vascular disease and arteriovenous fistula or infection in upper extremities are excluded from the study. Patients who need emergent intervention/s that last more than one hour are also excluded from the study. Randomization is done using sealed envelopes containing computer-generated block random allocation numbers.
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
- None
盲法说明
not blinded
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All adult patients (aged 18 or more) with upper extremity trauma who need procedural analgesia
排除标准
- •Patients with a history of seizure
- •Known allergy to analgesic substances
- •Sickle cell anemia,
- •Peripheral vascular disease and arteriovenous fistula
- •Infection in upper extremities
- •Patients who need emergent intervention/s that last more than one hour are also excluded from the study.
研究组 & 干预措施
Intravenous regional Analgesia
in this arm patients will receive intravenous regional anesthesia as infusion of mini dose (that is 1.5 mg/kg ) lidocaine 0.5% and immediately after procedure their torniquettes will be deflated (hence named Rapid MiniBier's block).
干预措施: Intravenous Regional Anesthesia (Procedure)
Systemic Analgesia
In this arm patients will receive ketamine 1-2 mg/kg IV slow as a systemic analgesia. ketamine as a PCP derivative has both hypnotic and analgesic effects.
干预措施: Systemic Analgesia (Drug)
结局指标
主要结局
pain score
时间窗: 30 minutes since the beginning of procedure
pain score assessed as numerical analogue score (NRS) with 1 for minimum and 10 for the maximum pain experienced by patient. A decrease of at least 13 millimeter will be considered as statistically meaningful.
次要结局
- Complications(30 minutes)
研究者
Mehdi Nasr Isfahani
Clinical Professor
Isfahan University of Medical Sciences