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.

术后疼痛每天有数百万患者经历 全世界。尽管有足够的药理学 特工，疼痛是术后最常遇到的疼痛之一 问题。关于急性疼痛不足的文档 在过去的十年中，主要的医疗保健问题已经广泛发生。 最近的证据表明医疗保健提供者很难 准确评估患者的镇痛要求。 技术 进步导致了患者控制的发展和接受 镇痛（PCA）治疗术后疼痛。然而， 关于药物输送的最佳方法，存在最小的研究 利用PCA疗法。越来越多的证据支持 疼痛敏感性和镇痛需求的时间变化 术后疼痛。这项研究的目的是评估时间 - 可能是疼痛评估和干预的依赖方法 由医疗保健提供者实施，以优化缓解疼痛。 使用正弦的基础治疗方案 输注模式将在随机的双重双 - 盲目的临床试验旨在比较时间治疗的功效 术后缓解疼痛的仅需PCA疗法与仅需求的PCA疗法。一般的 手术和骨科手术患者（n = 200）将是随机的 分配给只需需求或计时性治疗后外科手术 治疗方案。患者视觉模拟分数（VAS）的疼痛强度， 镇静，尝试自我管理镇痛和未实现 72小时的间隔将以4小时的间隔获得镇痛药的要求 术后期间。此外，肺不张，瘙痒的发生率 恶心，呕吐，尿位率，呼吸抑郁症， 范围内，过度修饰和住宿时间将通过图表获得 审查。前两个术后日的数据将使用 重复测量Mancova和Chi -Square分析以确定患者是否是否 接受时间治疗PCA方案的看法降低了 术后疼痛，较少的镇痛请求较少，更少 在通常的睡眠期间尝试自我管理镇痛药 与 接受标准的，仅需PCA的标准递送方案的患者。在 此外，镇痛自我管理的尝试数将会 与患者对每种疼痛强度的看法有关 评估护士对PCA泵使用的时间段 评估工具以验证患者对术后的看法 疼痛。这项研究的结果将为医疗保健专业人员提供 使用用于PCA治疗的年级治疗方案，这将是优越的 减轻手术后疼痛，同时减少手术后的疼痛 并发症。