Topical Lidocaine 2% Gel for Analgesia and Patient Comfort During Interscalene Brachial Plexus and Axillary Blocks: A Noninferiority Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Needle insertion pain
研究概览
简要总结
Skin infiltration with local anesthetic is commonly used to decrease patient discomfort during peripheral nerve blocks. Topically applied local anesthetic gel might provide analgesia while eliminating the need for additional injections. The primary objective of this study was a noninferiority comparison between the analgesia achieved with topical gel with that of skin infiltration for pain upon needle insertion and injection during administration of the interscalene brachial (ISBP) and axillary (AX) plexus blocks.
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 (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand Dutch, French or English language, purpose and risks of the study, provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations
- •Age >18 at the time of informed consent
- •ASA I-III physical class
- •Scheduled for elective shoulder or upper arm surgery requiring a preoperative interscalene brachial (ISBP) or axillary (AX) plexus block
排除标准
- •History of an allergy or contra-indication to a local anesthetic
- •Baseline neurological deficit
- •Medical condition that will make it difficult to assess sensory distribution or communicate with a staff member
- •Presence of preexisting coagulation disorders
- •Infection at injection site
- •Concomitant opioid therapy
- •Recent history (<3 months) of drug or alcohol abuse
- •Female subjects who are pregnant or currently breastfeeding, or who have a positive pregnancy test result at first visit
研究组 & 干预措施
Reference
干预措施: Lidocaine Topical (Drug)
New
干预措施: Lidocaine Topical (Drug)
结局指标
主要结局
Needle insertion pain
时间窗: Immediately at the time the needle is inserted through the skin
Pain rating (VAS)
Injection pain
时间窗: Immediately at the end of the block
Pain rating (VAS)
次要结局
- Fearfulness(Just before the nerve block)
- Overall discomfort(Immediately at the end of the block)
研究者
Catherine Vandepitte, M.D.
Anesthesiologist
Ziekenhuis Oost-Limburg