Bicket Mark C, Ladha Karim Shiraz, Haroutounian Simon, McFarlin Kellie, Neff Mary, McDuffie Rachel L, Waljee Jennifer F, Wijeysundera Duminda Nalaka, Brummet Chad, Li Yi
Department of Anesthesiology, University of Michigan, Ann Arbor, Michigan, USA
Department of Health Management and Policy, University of Michigan, Ann Arbor, Michigan, USA.
BMJ Open. 2025 Apr 5;15(4):e099925. doi: 10.1136/bmjopen-2025-099925.
Acute pain is commonly experienced by millions of patients who undergo outpatient surgical procedures. Moreover, an increasing number of procedures are performed on an outpatient basis, requiring greater postoperative planning to ensure effective pain management. Analgesic approaches commonly involve prescription opioids and non-steroidal anti-inflammatory drugs (NSAIDs), but an optimal regimen that balances pain and adverse effects has not been identified. In addition, critical gaps in evidence exist regarding how opioids and NSAIDs compare as analgesic regimens after surgery.
The Comparing Analgesic Regimen Effectiveness and Safety after Surgery (CARES) trial is a pragmatic, international, multicentre randomised trial that enrols adults undergoing three elective surgical procedures (laparoscopic cholecystectomy, breast lumpectomy, hernia repair). Participants are randomised to receive discharge analgesic prescriptions that consist of either NSAIDs or low-dose opioids (ie, 10 pills of oxycodone 5 mg or equivalent), with both groups prescribed acetaminophen around-the-clock. The primary effectiveness outcome is patient-reported worst daily pain intensity over the first 7 days after surgery. The primary safety outcome is the occurrence of opioid and/or NSAID side effects over the first 7 days after surgery. Secondary outcomes are assessed by patient report and medical record review at 1 week, 1 month, 3 months and 6 months after surgery and include sleep disturbance, patient perception of improvement/change after treatment, pain interference, anxiety, depression, health-related quality of life, clinically important adverse events, substance use, opioid misuse, chronic pain, healthcare utilisation related to pain and quality of recovery.
Investigational review boards at the University of Michigan and other sites have approved the CARES trial. The first patient enrolled in CARES in February 2023, with recruitment anticipated through 2026. Dissemination builds on the input of patient partners and other members of an engaged Stakeholder Advisory Board, with activities spanning co-production of summaries to share results with study participants, publications in biomedical journals and lay press, presentations to scientific and community organisations, and other multimedia communication materials.
NCT05722002.
数百万接受门诊手术的患者通常会经历急性疼痛。此外，越来越多的手术在门诊进行，这就需要更完善的术后规划以确保有效的疼痛管理。镇痛方法通常包括处方阿片类药物和非甾体抗炎药（NSAIDs），但尚未确定一种能平衡疼痛与不良反应的最佳方案。此外，关于阿片类药物和非甾体抗炎药作为术后镇痛方案的比较，证据方面存在重大差距。
术后镇痛方案有效性和安全性比较（CARES）试验是一项务实的国际多中心随机试验，纳入接受三种择期手术（腹腔镜胆囊切除术、乳房肿块切除术、疝气修补术）的成年人。参与者被随机分配接受出院镇痛处方，处方药物要么是NSAIDs，要么是低剂量阿片类药物（即10片5毫克羟考酮或等效药物），两组均持续服用对乙酰氨基酚。主要有效性结局是患者报告的术后前7天每日最严重疼痛强度。主要安全性结局是术后前7天阿片类药物和/或NSAIDs副作用的发生情况。次要结局通过患者报告以及术后1周、1个月、3个月和6个月的病历审查进行评估，包括睡眠障碍、患者对治疗后改善/变化的感知、疼痛干扰、焦虑、抑郁、与健康相关的生活质量、具有临床意义的不良事件、物质使用、阿片类药物滥用、慢性疼痛、与疼痛相关的医疗保健利用以及恢复质量。
密歇根大学和其他机构的研究审查委员会已批准CARES试验。第一名患者于2023年2月纳入CARES试验，预计招募工作将持续到2026年。传播工作基于患者合作伙伴和利益相关者咨询委员会其他成员的意见，活动包括共同制作总结以与研究参与者分享结果、在生物医学期刊和大众媒体上发表文章、向科学和社区组织进行展示以及其他多媒体宣传材料。
NCT05722002。
