EFFICACY OF CHRONOTHERAPEUTIC VS TRADITIONAL PCA THERAPY

时间疗法与传统 PCA 疗法的疗效

• 批准号: 2257922
• 负责人: SUSAN E AUVIL-NOVAK
• 金额: $ 25.09万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-09-30 至 1997-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2257922
• 关键词: analgesics; chronotherapy; data collection; drug administration rate /duration; drug adverse effect; drug delivery systems; human subject; human therapy evaluation; pain; pharmacokinetics; postoperative state; self care

Postoperative pain is experienced by millions of patients every day throughout the world. Despite the availability of adequate pharmacologic agents, pain is one of the most frequently encountered postoperative problems. Documentation concerning the undertreatment of acute pain as a major health care problem has occurred extensively within the past decade. Recent evidence indicates that health care providers have difficulty accurately assessing a patient's analgesic requirements. Technological advances have led to the development and acceptance of patient-controlled analgesia (PCA) therapy for treatment of postoperative pain. However, minimal research exists concerning the optimal method of drug delivery utilizing PCA therapy. Increasing evidence supports the existence of temporal variations in pain sensitivity and analgesic requirements in postoperative pain. The purpose of this study is to evaluate time- dependent approaches to pain assessment and intervention that may be implemented by health care providers to optimize pain relief. A chronotherapeutic treatment regimen employing a sinusoidal basal infusion pattern will be implemented and evaluated in a randomized double- blind clinical trial designed to compare the efficacy of chronotherapeutic versus demand-only PCA therapy for postoperative pain relief. General surgery and orthopedic surgery patients (N = 200) will be randomly assigned to either a demand-only or chronotherapeutic post-surgical treatment regimen. Patient visual analog scores (VAS) for pain intensity, sedation, attempts at self-administration of analgesic and unfulfilled requests for analgesic will be obtained at 4-hr intervals for a 72-hr period postoperatively. Further, incidence of atelectasis, pruritus, nausea, vomiting, urinary retention, respiratory depression, undersedation, oversedation and length of stay will be obtained by chart review. Data for the first two postoperative days will be analyzed using repeated measures MANCOVA and chi-square analyses to determine if patients receiving a chronotherapeutic PCA regimen have a diminished perception of post.operative pain, fewer unfulfilled requests for analgesic, fewer attempts at self-administration of analgesic during the usual sleep period and a decreased incidence of post-operative complications when compared to patients receiving the standard, demand-only PCA delivery regimen. In addition, the number of attempts of self-administration of analgesic will be correlated with the patient's perception of pain intensity for each time period to evaluate the use of the PCA pump by nurses as a pain assessment instrument to validate patients' perception of post-operative pain. The results of this study will provide health care professionals with a chronotherapeutic regimen for PCA therapy that will be superior in reducing post-surgical pain while concurrently decreasing post-surgical complications.

每天有数百万患者经历术后疼痛 全世界。尽管有足够的药物 疼痛是术后最常遇到的问题之一 问题。有关急性疼痛治疗不足的文件 过去十年来，重大医疗保健问题广泛发生。 最近的证据表明，医疗保健提供者面临困难 准确评估患者的镇痛需求。 技术性 进步导致了患者控制的发展和接受 镇痛（PCA）疗法用于治疗术后疼痛。然而， 关于最佳药物输送方法的研究很少 利用 PCA 疗法。越来越多的证据支持存在 疼痛敏感性和镇痛需求的时间变化 术后疼痛。本研究的目的是评估时间 疼痛评估和干预的依赖方法可能是 由医疗保健提供者实施，以优化疼痛缓解。 采用正弦曲线基础的时间治疗方案 输注模式将在随机双试验中实施和评估 旨在比较时间疗法疗效的盲法临床试验 与仅按需 PCA 治疗缓解术后疼痛的比较。一般的 手术和骨科手术患者（N = 200）将被随机分组 分配给仅需求或时间治疗术后 治疗方案。患者疼痛强度视觉模拟评分 (VAS)， 镇静，尝试自行服用镇痛剂但未实现 72 小时内将每隔 4 小时收到一次镇痛请求 术后一段时间。此外，肺不张、瘙痒、 恶心、呕吐、尿潴留、呼吸抑制、 镇静不足、镇静过度和住院时间将通过图表获得 审查。术后前两天的数据将使用以下方法进行分析 重复测量 MANCOVA 和卡方分析以确定患者是否 接受时间治疗 PCA 方案的人的感知能力减弱 术后疼痛、未满足的镇痛请求减少、 在平时的睡眠期间尝试自行服用镇痛药 与相比，术后并发症发生率降低 接受标准、按需 PCA 给药方案的患者。在 此外，尝试自行施用镇痛药的次数 与患者对每种疼痛强度的感知相关 评估护士使用 PCA 泵是否疼痛的时间段 评估工具来验证患者对术后的感知 疼痛。这项研究的结果将为医疗保健专业人员提供 PCA 治疗的时间治疗方案将在以下方面更优越 减少术后疼痛，同时减少术后疼痛 并发症。