Onset and Duration of Forearm Nerve Blockade Performed With a Single Distal Injection Versus Sequential Injections at Distal and Proximal Locations Alongside the Nerves: A Blinded Randomized
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
研究概览
简要总结
This pilot study will evaluate the latency of onset and duration of sensory-motor block in patients undergoing hand surgery. Patients will be randomized to receive nerve blocks of the distal forearm or of the distal and proximal forearm. Local anesthetic will be injected to anesthetise the median and ulnar nerves in the distal forearm (1-injection site group) or the median and ulnar nerves in the distal and proximal forearm (2-sequential injection sites group) to accomplish anesthesia for surgery on the hand.
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)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Scheduled to undergo daycare surgery for carpal tunnel syndrome under peripheral nerve blocks
- •American Society of Anesthesiologists (ASA) physical status I, II or III
- •Able to demonstrate sensory function in the ulnar and median nerve distribution by exhibiting sensitivity to cold, pinprick and light touch
- •Scheduled to undergo primary hand surgery
- •Able to understand the Dutch language, purpose and risks of the study
- •Able to provide informed consent and authorization to use protected health information, adhere to the study visit schedule, and complete all study assessments
排除标准
- •Currently pregnant or nursing
- •History of hypersensitivity to local anesthetics
- •Contraindication to lidocaine, bupivacaine, paracetamol
- •Medical condition that will make it difficult to assess sensory distributions of the upper extremity peripheral nerves or to communicate with staff
- •Suspected or known recent history (< 3 months) of drug or alcohol abuse
- •Concurrent physical condition that may require analgesic treatment (such as NSAID or opioid) in the postsurgical period for pain that is not strictly related to Carpal Tunnel Syndrome and which may confound the postsurgical assessments
- •Infection at the planned block site(s)
- •Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®)
- •Body weight <40 kg or body mass index >44 kg/m2
- •Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments
- •Any chronic neuromuscular deficit affecting the Ulnar and Median nerves or muscles of the surgical extremity
- •Any chronic condition or disease that would compromise neurological
- •Presence of pre-existing coagulation disorders
- •Baseline neurological deficits
研究组 & 干预措施
Lidocaine distal forearm
Lidocaine 1% - Ultrasound-guided specific blocks of the DISTAL median and ulnar nerves with perineural injections of Lidocaine1%. Volume injected is 6 mL/nerve; 12 mL total.
干预措施: Lidocaine (Drug)
Bupivacaine distal forearm
Bupivacaine 0.5%-Ultrasound-guided specific blocks of the DISTAL median and ulnar nerves with perineural injections of Bupivacaine0.5%. Volume injected is 6 mL/nerve; 12 mL total.
干预措施: Bupivacaine (Drug)
Lidocaine distal and proximal forearm
Lidocaine 1%- Ultrasound-guided specific blocks of the DISTAL and PROXIMAL median and ulnar nerves with perineural injections of Lidocaine 1%. Volume injected is 3 mL/nerve; 12 mL total
干预措施: Lidocaine (Drug)
Bupivacaine distal and proximal forearm
Bupivacaine 0.5%- Ultrasound-guided specific blocks of the DISTAL and PROXIMAL median and ulnar nerves with perineural injections of Bupivacaine 0.5 %. Volume injected is 3 mL/nerve; 12 mL total.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
时间窗: Post Anesthesia Care Unit discharge
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves. Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
次要结局
- postoperative Numeric Rating Scale (NRS)(Day 30)
研究者
Catherine Vandepitte, M.D.
Medical Doctor
New York School of Regional Anesthesia