A Randomized Controlled Trial to Investigate the Efficacy of a Bier's Block Compared to a Mini-bier's Block in Patients Undergoing Hand Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Sensory and motor block of the hand
研究概览
简要总结
By means of an observer-blinded, randomized controlled trial, the analgesic efficacy of an upper-arm Bier's block and a forearm mini-Bier's block will be investigated in patients undergoing hand surgery. The hypothesis is that there is no difference between the two types of anesthetic techniques with respect to the analgesic efficacy.
详细描述
Introduction:
Several ways of anesthesia can be used to perform hand surgery, being general anesthesia, intravenous regional anesthesia as well as locoregional anesthesia. Locoregional anesthesia and intravenous regional anesthesia are often performed since patients can be discharged from the hospital more rapidly.
A conventional Bier's block is performed using a tourniquet on the upper arm to create a bloodless field and to contain the anesthetics within the surgical area (1). Complications are rare but are often linked to a systemic toxicity reaction after releasing the tourniquet (2). A mini-Bier's block in which the tourniquet is placed on the fore-arm, has been shown to be a safe and effective way of anesthesia to perform hand surgery. By using this type of anesthesia, the dose of the anesthetic can be reduced compared to a conventional Bier's block which reduces the risk of systemic toxicity reactions (3-5).
Currently, studies that made a comparison between the two anesthesia techniques are scarce and inconsistent. Next to that, those studies also used different types of anesthetics and dosages. To see which technique is advantageous in clinical practice, the investigators want to investigate the efficacy of the Bier's block and mini-Bier's block in patients that are planned to undergo hand surgery.
Outcome measures:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females ≥ 18 years of age
- •American Society of Anesthesiology (ASA) physical status classification: 1-3
- •Patients planned to undergo hand surgery which can be performed using either a Bier's block or a mini-Bier's block
排除标准
- •< 18 years old
- •Patients that participate in other clinical, pharmaceutical trials or trials with medical devices
- •Patients that previously have been randomized in this trial
- •Patients that need to undergo surgery using sedation/general anesthesia
- •Bilateral surgery
- •BMI ≥ 40 kg/m2
- •History of neurological conditions
- •Chronic pain symptoms
- •Concomitant use of Opioids in the last month
- •Diabetes mellitus with organ damage
- •Oversensitivity to local anesthetics
- •Blood clotting disorders
- •Inability to understand and adhere to the study design
结局指标
主要结局
Sensory and motor block of the hand
时间窗: 5 minutes after injection of lidocaine 0.5%
This study wants to evaluate and compare the analgesic efficacy of the Bier's block with the mini-Bier's block. The blinded surgeon will assess the analgesic effectivity and grade it as either complete (grade 1 and grade 2) or incomplete (grade 3 and grade 4). Grade 1 is defined as complete motor and sensory blockade; grade 2 is defined as partial motor blockade with no pain or deep pressure sensitivity. Grade 3 is defined as partial motor blockade with mild pain and the need for rescue local or opioid analgesia. Grade 4 is defined as incomplete motor and sensory blockade requiring sedation/conversion to general anesthesia.
次要结局
- Pain due to anesthesia technique: Numeric Rating Scale (NRS)(At the end of performing the anesthesia technique)
- Tourniquet time(From start of inflation until deflation of the tourniquet)
- Time of surgical procedure(From start of surgical incision until closing of the surgical wound)
- Intraoperative pain score: Numeric Rating Scale (NRS)(every 5 min during the surgical procedure)
- Satisfaction with surgical conditions (bloodless field) assessed by the surgeon with a 5-point likert scale(At the start of the surgical procedure)
- General satisfaction of the patient: Likert scale(Assessed on day 1 post surgery)
- Pre-operative pain score: Numeric Rating Scale (NRS)(Before the start of anesthesia technique)
- Tourniquet tolerance time(From start of inflation until deflation of the tourniquet)
- Time in operating room(From entering the operating room until leaving the operating room)
- Onset time of analgesia(At injection of the anaesthetic until complete blockade of the sensory nerves)
- Pain score at start of surgery (surgical incision): Numeric Rating Scale (NRS)(At the start of the surgical procedure)
研究者
Stessel Björn
Principal Investigator, Anesthesiologist, MD, PhD
Jessa Hospital