Gilron Ian, Kehlet Henrik, Pogatzki-Zahn Esther
Department of Anesthesiology & Perioperative Medicine, Queen's University, Kingston, Ontario, Canada.
Department of Biomedical & Molecular Sciences, Queen's University, Kingston, Ontario, Canada.
Can J Pain. 2019 Jul 30;3(2):36-43. doi: 10.1080/24740527.2019.1583044. eCollection 2019.
: Clinical trials remain vital in order to: A) develop new treatment interventions, and also, B) to guide optimal use of current interventions for the treatment and prevention of acute and chronic postsurgical pain. Measures of pain (e.g. intensity and relief) and opioid use have been validated for the settings of postsurgical pain and continue to effectively guide research in this field.. : This narrative review considers needs for innovation in postsurgical pain trial outcomes assessment. : Future improvements are needed and include: A) more widespread measurement of movement-evoked pain with validation of various procedure-relevant movemen-tevoked pain maneuvers; B) new validated analytical approaches to integrate early postoperative pain scores with opioid use; and, C) closer attention to the measurement of postoperative opioid use after hospital discharge. In addition to these traditional measures, consideration is being given to the use of new pain-relevant outcome domains that include: 1) other symptoms (e.g. nausea and vomiting), 2) recovery of physiological function (e.g. respiratory, gastrointestinal, genitourinary and musculoskeletal), 3) emotional function (e.g. depression, anxiety) and, 4) development of chronic postsurgical pain. Also, there is a need to develop pain-related domains and measures for evaluating both acute and chronic post-operative pain. Finally, evidence suggests that further needs for improvements in safety assessment and reporting in postsurgical pain trials is needed, e.g. by using an agreed upon, standardized collection of outcomes that will be reported as a minimum in all postsurgical pain trials. : These proposed advances in outcome measurement methodology are expected to improve the success by which postsurgical pain trials guide improvements in clinical care and patient outcomes.
临床试验仍然至关重要,目的如下:A)开发新的治疗干预措施;B)指导当前干预措施在治疗和预防急慢性术后疼痛中的最佳应用。疼痛测量指标(如强度和缓解程度)以及阿片类药物的使用已在术后疼痛环境中得到验证,并继续有效指导该领域的研究。
本叙述性综述探讨了术后疼痛试验结果评估中的创新需求。
未来需要改进的方面包括:A)更广泛地测量运动诱发疼痛,并验证各种与手术相关的运动诱发疼痛操作;B)采用新的经过验证的分析方法,将术后早期疼痛评分与阿片类药物使用情况相结合;C)更加关注出院后术后阿片类药物使用情况的测量。除了这些传统指标外,还在考虑使用与疼痛相关的新结局领域,包括:1)其他症状(如恶心和呕吐);2)生理功能恢复(如呼吸、胃肠、泌尿生殖和肌肉骨骼功能);3)情绪功能(如抑郁、焦虑);4)慢性术后疼痛的发生。此外,还需要开发用于评估急性和慢性术后疼痛的与疼痛相关的领域和测量方法。最后,有证据表明,术后疼痛试验在安全评估和报告方面还需要进一步改进,例如通过使用商定的标准化结局收集方法,所有术后疼痛试验至少都应报告这些结局。
这些在结局测量方法上的提议进展有望提高术后疼痛试验指导临床护理改善和患者结局的成功率。
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