Efficacy of Ultrasound-guided Axillary Nerve Block Versus Ultrasound-guided Peripheral Forearm Block in Patients Undergoing Hand Surgery: 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
- 80
- 试验地点
- 1
- 主要终点
- Total anaesthesia-related time
研究概览
简要总结
By means of an observer-blinded, mono-center, prospective, randomized controlled superiority trial, the total anesthesia-related time (sum of performance and onset times) of an ultrasound-guided distal peripheral nerve block and an ultrasound-guided axillary nerve block will be investigated in patients undergoing hand surgery. The hypothesis is that the onset-time of the ultrasound-guided distal peripheral nerve block will be faster than ultrasound-guided axillary nerve blocks, which is more suitable for hand surgery.
详细描述
Introduction:
Regional anesthesia (RA) has become an increasingly popular alternative for general anesthesia in day-care hand surgery. It has been demonstrated to allow faster recovery and to reduce time to discharge from the hospital (lower pain scores, less nausea, ... ), resulting in lower hospital costs.
An ultrasound-guided distal peripheral nerve block of the n. medianus and n. ulnaris is frequently used in locoregional anesthetic technique in superficial hand surgery. Distal peripheral nerve blocks allow preservation of proximal muscle function of the upper limb, which may also allow patients to move affected digits when instructed to do so during surgery.
Another frequently used locoregional technique in superficial hand surgery is the axillary nerve block. An ultrasound-guided axillary nerve block anesthetizes the n. medianus, n. ulnaris, n. radialis, and n. musculocutaneous at an early stage in their trajectory in the arm, providing satisfactory anesthesia for elbow, forearm, and hand surgery and provides reliable cutaneous anesthesia of the inner upper arm including the medial cutaneous nerve of the arm and intercostobrachial nerve, areas often missed with other approaches.
Ambulatory superficial hand surgery is frequently conducted in JESSA hospital and is most frequently conducted using intravenous regional anesthesia (IVRA) of the forearm, an ultrasound-guided distal peripheral nerve block, or an ultrasound-guided axillary nerve block.
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
- Triple (Care Provider, Investigator, 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
- 否
入选标准
- •≥18 years old
- •ASA (American Society of Anesthesiology) classification: 1 - 3
- •Scheduled for surgery in the day surgery unit
- •Patients planned for unilateral hand surgery: carpal tunnel release, finger amputation (except digit I and II), finger manipulation (except digit I and II), hand foreign body removal (except digit I and II), hand incision and drainage, metacarpal fracture repair (except digit I and II), trigger finger release (except digit I), tendon repair (except digit I), and Dupuytren's contracture (except digit I)
排除标准
- •Refusal of the patient
- •Bilateral surgery
- •BMI ≥ 40 kg/m²
- •Puncture site infections
- •Preexisting peripheral neuropathy
- •Chronic pain syndrome
- •Diabetes mellitus
- •Pregnancy
- •Use of strong pain medication in the past 3 months
- •Allergy for any of the medications used
- •Coagulation disorders or the use of anticoagulant therapy (vitamin K antagonists, new oral anticoagulants) or antiplatelet drugs (thienopyridines)
- •Contra-indication for the use of a tourniquet
- •Previous surgery in the same upper extremity
- •Impossibility to understand the study protocol
- •Not understanding the Dutch language
结局指标
主要结局
Total anaesthesia-related time
时间窗: Preoperative
The total anesthesia-related time is the sum of block performance time and onset time of the block. Block performance time is defined as the time interval between the start of the block procedure and the end of the block procedure, thus imaging + needling time. Block performance time will be recorded with a stopwatch by the attending block room nurse. Time for the sensory block to take effect is defined as the time required for the limb to achieve a level of anesthesia deemed adequate for surgery (i.e., not necessarily a complete block) after placement of the block.
次要结局
- Surgical block success rate(Intraoperative)
- Patient satisfaction(Day 0 and day 1 postoperatively)
- Needling time(Preoperative)
- Surgical time(Intraoperative)
- Total OR stay time(Intraoperative)
- Tourniquet time(From start of inflation until deflation of the tourniquet)
- Intraoperative need for supplemental analgesia(Intraoperative)
- The conversion rate to general analgesia(Intraoperative)
- Tourniquet tolerance time(From start of inflation until deflation of the tourniquet)
- Pain due to anesthesia technique: Numeric Rating Scale (NRS)(At the end of performing the anesthesia technique)
- Pain score at start of surgery (surgical incision): Numeric Rating Scale (NRS)(At the start of the surgical procedure)
- Intraoperative pain score: Numeric Rating Scale (NRS)(Every 5 minutes during the surgical procedure, until the end of surgery (last stitch) (up to 25 minutes))
- Postoperative pain score: Numeric Rating Scale (NRS)(Day 0 and day 1 postoperatively)
- Required doses of intraoperative pain medication(Intraoperative)
- Surgical satisfaction(At the end of the surgery)
- Required doses of postoperative pain medication(Day 1 postoperatively)
- Adverse events(Day 1 postoperative)
研究者
Stessel Björn
Principal Investigator
Jessa Hospital