Efficacy of Ultrasound-guided Peripheral Nerve Block Versus Forearm Bier's Block in Patients Undergoing Carpal Tunnel Release: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Analgesic effectivity
研究概览
简要总结
By means of an observer-blinded, randomized controlled trial, the analgesic efficacy of the forearm intravenous regional anesthesia and the ultrasound guided peripheral nerve block will be investigated in patients undergoing carpal tunnel release. The hypothesis is that the ultrasound-guided peripheral nerve block is superior compared to the forearm intravenous regional anesthesia with respect to the analgesic efficacy.
Furthermore, pre-, intra-, and post-operative pain will be investigated at several time points as well as general patient satisfaction and satisfaction of the surgeon regarding the procedures.
详细描述
Introduction:
In Belgium, several ways of anesthesia are 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 forearm intravenous regional anesthesia (IVRA; mini-Bier's block) is an effective and safe technique to perform hand surgery, especially since the dose of the used anesthetic is reduced compared to a regular upper arm Bier's block, leading to a reduced risk of local anesthetic toxicity. An ultrasound-guided distal peripheral nerve block is often used for hand surgery, in which the nervus medianus and the nervus ulnaris can be affected locally. Research showed that this technique is associated with a reduced surgical procedure time when compared to intravenous regional anesthesia (1). In the Jessa Hospital, a carpal tunnel release is often performed using the forearm intravenous regional anesthesia. However, to date, the analeptic effectivity of the forearm intravenous regional anesthesia has not been compared to the distal peripheral nerve block.
Outcome measures:
The primary aim of this study is to compare the analgesic effectivity of the forearm intravenous regional anesthesia versus the ultrasound-guided distal peripheral nerve block. Our hypothesis is that the latter technique is superior. A blinded surgeon will determine the analgesic effectivity of these techniques (graded as "complete" or "incomplete") and divide the effectivity in 4 grades. Grade 1 and grade 2 are considered "complete" blockade, while grade 3 and grade 4 are considered "incomplete" blockade. Grade 1: complete motor and sensory blockade, grade 2: partial motor blockade but no pain or deep pressure sensitivity, grade 3: partial motor blockade with mild pain requiring rescue local or opioid analgesia, grade 4: incomplete motor- and sensory blockade requiring sedation/conversion to general anesthesia). Secondary study outcomes are patient's pre-, intra-, and post-operative pain scores at several time points, measured via an 11-point Numeric Rating Scale (NRS) in which number 0 means "no pain at all", number 5 means "moderate pain" and number 10 means "worst possible pain". General patient satisfaction as well as satisfaction of the surgeon regarding the used technique will be measured via a 7-point Likert Scale, in which number 1 means "extremely dissatisfied" and number 7 means "extremely satisfied". Furthermore, the time spend in the operating room, the time of surgical procedure and the use of post-operative medication use will be recorded as well.
Design:
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 carpal tunnel release via regional anesthesia (intravenous regional anesthesia or ultra-sound guided peripheral nerve block)
排除标准
- •Bilateral surgery
- •BMI ≥ 40 kg/m2
- •Infection in the area of the peripheral nerve block injection site
- •History of neurological conditions
- •Chronic pain symptoms
- •Concomitant use of Opioids in the last 3 months
- •Diabetes mellitus type-1 (insulin dependent diabetes mellitus)
- •Diabetes mellitus with organ damage
- •Oversensitivity to local anesthesia
- •Blood clotting disorder
- •History of any surgical procedure in the arm that needs to be operated
- •Inability to understand and adhere to the study design
结局指标
主要结局
Analgesic effectivity
时间窗: Intraoperative
This study wants to evaluate and compare the analgesic effectivity of the intravenous regional anesthesia (IVRA; mini-Bier's block) and the ultrasound-guided peripheral nerve 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
- Time in operating room(Intraoperative)
- Post-operative pain(1 day)
- Patient satisfaction(1 day)
- Pre operative pain(Intraoperative)
- Time of surgical procedure(Intraoperative)
- Intra-operative: pain(Intraoperative)
- Use of post-operative pain medication(1 day)
- Surgeon satisfaction(1 day)
研究者
Stessel Björn
Principal Investigator, Anesthesiologist, MD, PhD
Jessa Hospital
