OPTIMIZING LOCAL ANESTHETIC CONCENTRATION FOR CONTINUOUS PERIPHERAL NERVE BLOCKS

优化连续周围神经阻滞的局部麻醉浓度

• 批准号: 7717109
• 负责人: Linda T Le
• 金额: $ 0.14万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717109
• 关键词: Absence of pain sensation; Adverse effects; Analgesics; Anesthetics; Bolus Infusion; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Consumption; Dose; End Point; Event; Funding; Grant; Infusion procedures; Institution; Limb structure; Local Anesthetics; Masks; Nerve Block; Numbers; Numbness; Operative Surgical Procedures; Orthopedic Procedures; Pain; Patients; Peripheral Nerves; Pharmaceutical Preparations; Postoperative Period; Randomized; Rate; Research; Research Personnel; Resources; Score; Sleep disturbances; Source; Testing; United States National Institutes of Health; Upper arm; base; experience; perineural; ropivacaine; satisfaction

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The moderate-to-severe pain many patients experience following orthopedic procedures is now often being treated with a perineural local anesthetic infusion?or continuous peripheral nerve block?providing potent analgesia with very rare side effects. However, it remains unknown whether local anesthetic concentration, or simply total drug dose, is the primary determinant of analgesia and limb numbness. The result is that clinicians use both lower concentration local anesthetics at a higher rate of infusion, and higher concentration local anesthetics at a lower rate of infusion?based on their own experiences and biases rather than the results of formal studies. Consequently, patients may receive inadequate analgesia or experience a numb extremity. We therefore propose to test the null hypothesis that differing the concentration (0.2% vs. 0.4%) but providing an equal total dose of ropivacaine has no impact on the number of incident numbness events. The proposed study is a multicenter, randomized, observer-masked, controlled, parallel-arm clinical investigation involving patients receiving a perineural local anesthetic infusion for postoperative analgesia following moderate-to-severely painful surgery. Patients will be randomized to receive a local anesthetic?ropivacaine?at either 0.2% or 0.4%. However, basal infusion rate and bolus volume will be doubled in the 0.2% treatment group resulting in the same total delivered ropivacaine dose. The primary endpoint will involve extremity numbness; and secondary endpoints will include pain scores, bolus-dose use, volume of anesthetic consumption, duration of anesthetic delivery, sleep disturbances, and satisfaction with analgesia.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 许多患者在骨科手术后经历的中度至重度疼痛现在通常采用神经周围局部麻醉输注或持续周围神经阻滞来治疗，提供有效的镇痛效果且副作用非常罕见。 然而，目前尚不清楚局部麻醉药浓度或总药物剂量是否是镇痛和肢体麻木的主要决定因素。 结果是，临床医生根据自己的经验和偏见，而不是正式研究的结果，在较高的输注速度下使用较低浓度的局部麻醉剂，并在较低的输注速度下使用较高浓度的局部麻醉剂。 因此，患者可能会收到不充分的镇痛或出现四肢麻木。 因此，我们建议检验原假设，即不同浓度（0.2% 与 0.4%）但提供相同总剂量的罗哌卡因对麻木事件的发生次数没有影响。 拟议的研究是一项多中心、随机、观察者掩蔽、对照、平行临床研究，涉及患者在中度至重度疼痛的手术后接受神经周围局部麻醉输注以进行术后镇痛。 患者将被随机分配接受 0.2% 或 0.4% 的局部麻醉剂罗哌卡因。 然而，0.2%治疗组的基础输注速率和推注体积将加倍，导致罗哌卡因的总递送剂量相同。 主要终点将涉及四肢麻木；次要终点包括疼痛评分、推注剂量使用、麻醉药消耗量、麻醉药持续时间、睡眠障碍和镇痛满意度。