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; 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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 现在，许多患者经历了骨科手术的中度到重度疼痛。 然而，尚不清楚局部麻醉浓度是镇痛和肢体麻木的主要决定因素。 结果是，临床医生以较高的输注率使用较低的局部麻醉剂，也以较低的局部麻醉率使用较高的局部麻醉剂，以较低的输注率？基于他们自己的经验和偏见，而不是正式研究的结果。 因此，患者可能会接受镇痛不足或肢体麻木。 因此，我们建议检验零假设，即浓度有所不同（0.2％和0.4％），但提供相等的总剂量ropopivacaine对事件麻木事件的数量没有影响。 拟议的研究是一项多中心，随机，观察者掩盖的，受控的，平行的临床研究，涉及接受中度性局部麻醉性术后术后镇痛的患者进行中度到术后疼痛手术。 患者将被随机接受局部麻醉剂？ropivacaine？以0.2％或0.4％的速度接受。 但是，在0.2％的治疗组中，基础输注率和推注量将增加一倍，从而导致总递送的ropivacaine剂量。 主要终点将涉及肢体麻木。次要终点将包括疼痛评分，推注剂量的使用，麻醉消耗量，麻醉量的持续时间，睡眠障碍以及对镇痛的满意度。