Venturini Monica Aida, Zappa Sergio, Minelli Cosetta, Bonardelli Stefano, Lamberti Laura, Bisighini Luca, Zangrandi Marta, Turin Maddalena, Rizzo Francesco, Rizzolo Andrea, Latronico Nicola
Department of Anesthesia, Critical Care Medicine and Emergency, University of Brescia at Spedali Civili, Brescia, Italy.
National Heart and Lung Institute, Imperial College London, London, UK.
BMJ Open. 2015 Dec 16;5(12):e009137. doi: 10.1136/bmjopen-2015-009137.
Magnesium exerts analgaesic effects in several animal pain models, as well as in patients affected by acute postoperative pain and neuropathic chronic pain. There is no evidence that magnesium can modulate pain in patients with peripheral arterial occlusive disease (PAOD). We describe the protocol of a single-centre randomised double-blind clinical trial aimed at assessing the efficacy of oral magnesium supplementation in controlling severe pain in patients with advanced PAOD.
Adult patients affected by PAOD at stages III and IV of Lèriche-Fontaine classification, who are opioid-naïve, and who have been admitted to our Acute Pain Service for intractable pain, will be eligible. Patients will be randomised to the control group, treated with standard therapy (oxycodone and pregabalin) plus placebo for 2 weeks, or to the experimental group (standard therapy plus magnesium oxide). Patients will be evaluated on days 0, 2, 4, 6, 8, 12 and 14; the following information will being collected: daily oxycodone dose; average and maximum pain (Numerical Rating Scale); pain relief (Pain Relief Scale); characteristics of the pain (Neuropathic Pain Scale); impact of pain on the patient's daily activities (Brief Pain Inventory). The primary outcome will be oxycodone dosage needed to achieve satisfactory analgaesia on day 14. Secondary outcomes will be pain relief on day 2, time needed to achieve satisfactory analgaesia and time needed to achieve a pain reduction of 50%. A sample size calculation was performed for the primary outcome, which estimated a required sample size of 150 patients (75 per group).
Ethical approval of the study protocol has been obtained from Comitato Etico Provinciale di Brescia, Brescia, Italy. Trial results will be disseminated through scientific journal manuscripts and scientific conference presentations.
NCT02455726.
镁在多种动物疼痛模型以及急性术后疼痛和神经性慢性疼痛患者中具有镇痛作用。尚无证据表明镁能调节外周动脉闭塞性疾病（PAOD）患者的疼痛。我们描述了一项单中心随机双盲临床试验方案，旨在评估口服补充镁对控制晚期PAOD患者严重疼痛的疗效。
符合条件的患者为勒里什 - 方丹分类III期和IV期的PAOD成年患者，这些患者未使用过阿片类药物，因顽固性疼痛入住我们的急性疼痛服务中心。患者将被随机分为对照组，接受标准治疗（羟考酮和普瑞巴林）加安慰剂治疗2周，或实验组（标准治疗加氧化镁）。将在第0、2、4、6、8、12和14天对患者进行评估；收集以下信息：每日羟考酮剂量；平均和最大疼痛程度（数字评分量表）；疼痛缓解情况（疼痛缓解量表）；疼痛特征（神经性疼痛量表）；疼痛对患者日常活动的影响（简明疼痛问卷）。主要结局将是第14天达到满意镇痛所需的羟考酮剂量。次要结局将是第2天的疼痛缓解情况、达到满意镇痛所需的时间以及疼痛减轻50%所需的时间。对主要结局进行了样本量计算，估计所需样本量为150名患者（每组75名）。
该研究方案已获得意大利布雷西亚省伦理委员会的伦理批准。试验结果将通过科学期刊稿件和科学会议报告进行传播。
NCT02455726。
