Nygaard Kevin Heebøll, Strøm Thomas, Specht Kirsten, Petersen Sofie Ronja, Schønnemann Jesper Ougaard
Department of Orthopedics, University Hospital of Southern Denmark, Kresten Philipsensvej 15, Aabenraa, 6200, Denmark.
Department of Anesthesiology and Intensive Care, University Hospital of Southern Denmark, Kresten Philipsensvej 15, Aabenraa, 6200, Denmark.
Trials. 2024 Dec 20;25(1):842. doi: 10.1186/s13063-024-08694-6.
Hip fractures are a source of severe pain among the elderly population and pose challenges due to limited analgesic tolerance. Perioperative methadone has shown promise in our pilot study suggesting a safe dose of 0.10 mg/kg, prompting further investigation into its benefits for elderly hip fracture patients.
This study employs a double-blinded randomized controlled trial to assess the analgesic effects of a single dose of methadone during hip fracture surgery. Patients aged ≥ 60 years are consecutively enrolled and randomized to receive either perioperative methadone (treatment group) or a saline solution (placebo group). A sample size of 130 patients is required for 88% statistical power. The medication is administered intravenously at anesthesia induction and monitored until discharge. A follow-up observation is conducted 3 months post-surgery.
Primary outcome: Daily consumption of opioids within the first 3 days after surgery. Secondary outcomes include pain, mobility, nausea, vomiting, time to discharge, need for antidote, delirium, and constipation. The 3-month follow-up includes opioid use, pain, EQ-5D-5L scores, mobility, and persistent side effects. If statistically significant advantages are found in the treatment group, perioperative methadone could be considered as standard care for hip fracture patients, potentially enhancing their pain management. The study's outcomes will provide insights into the feasibility and effectiveness of incorporating methadone into routine clinical practices for this patient group.
ClinicalTrials.gov ID: NCT06086171, submitted 4. October 2023.
EU-CT: 2023-506252-24-00, UTN: U1111-1294-6125.
髋部骨折是老年人群严重疼痛的一个来源，并且由于镇痛耐受性有限而带来挑战。围手术期美沙酮在我们的初步研究中显示出前景，表明安全剂量为0.10毫克/千克，这促使对其对老年髋部骨折患者的益处进行进一步研究。
本研究采用双盲随机对照试验来评估单剂量美沙酮在髋部骨折手术期间的镇痛效果。年龄≥60岁的患者连续入组并随机分为接受围手术期美沙酮治疗组（治疗组）或生理盐水组（安慰剂组）。为达到88%的统计效能，需要130名患者的样本量。药物在麻醉诱导时静脉给药，并监测至出院。术后3个月进行随访观察。
主要结局：术后前3天内阿片类药物的每日消耗量。次要结局包括疼痛、活动能力、恶心、呕吐、出院时间、解毒剂需求、谵妄和便秘。3个月随访包括阿片类药物使用情况、疼痛、EQ-5D-5L评分、活动能力和持续的副作用。如果在治疗组中发现具有统计学意义的优势，则围手术期美沙酮可被视为髋部骨折患者的标准治疗方法，可能会改善他们的疼痛管理。该研究的结果将为将美沙酮纳入该患者群体的常规临床实践的可行性和有效性提供见解。
ClinicalTrials.gov标识符：NCT06086171，于2023年10月4日提交。
2023-506252-24-00，UTN：U1111-1294-6125。
