EUCTR2017-003694-34-BE进行中(未招募)1 期
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 controlled trial. - 2-HIT
Ziekenhuis Oost-Limburg0 个研究点目标入组 36 人开始时间: 2017年10月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- adult patients between 18 and 80 years
- •- scheduled to undergo daycare surgery for carpal tunnel syndrome or Dupuytren's contracture release under peripheral nerve blocks
- •- ASA I, II or III
- •- Able to demonstrate sensory function 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •?Currently pregnant or, nursing patients
- •?History of hypersensitivity to local anesthetics
- •?Contraindication to bupivacaine, paracetamol, ketorolac, oxycodone or morphine
- •?Medical condition that will make it difficult to assess sensory distributions of 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 Dupuytren’s contracture and which may confound the postsurgical assessments
- •?Infection at the planned block site
- •?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 (88 pounds) or a body mass index >44 kg/m2
- •?Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments
- •?Any chronic neuromuscular deficit affecting the peripheral nerves or muscles of the surgical extremity
- •?Any chronic condition or disease that would compromise neurological or vascular assessments
- •?Presence of preexisting coagulation disorders
- •?Baseline neurological deficits
研究者
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