Licina Ana, Russell Jeremy, Silvers Andrew, Jin Xin, Denny Jason
Anaesthesia, Austin Health, Heidelberg, Victoria, Australia
Neurosurgery, Austin Health, Heidelberg, Victoria, Australia.
BMJ Open. 2019 Aug 18;9(8):e032388. doi: 10.1136/bmjopen-2019-032388.
Postcraniotomy pain protocols use opioids, which are considered suboptimal analgesia following this procedure. Multimodal analgesia components are sparse. Our null hypothesis states that sumatriptan is not different to placebo in addition to usual intravenous opioids, for the treatment of acute postcraniotomy pain.
This is a prospective single-centre randomised double-blinded placebo-controlled phase III clinical trial comparing subcutaneous sumatriptan injection in the recovery area with placebo for the treatment of postcraniotomy pain. Eligible adult patients (18 years and older) undergoing craniotomy will be identified preoperatively. Both patient groups will receive a subcutaneous injection at a point where recovery-nursing staff would initiate the usual intravenous opioid analgesia as per standardised pain management protocol. In both groups, further pain management will be followed by the usual intravenous opioid administration. Primary outcome will consist of the difference in pain experienced by the two groups of patients in recovery area 60 min after the study drug administration. Postcraniotomy pain will be measured at regular intervals using the Visual Analogue Scale (VAS) in recovery area. The minimal clinically important difference of 10 mm on the VAS between the two groups will be considered as statistically significant. We will include selected clinical and patient-reported outcomes as secondary endpoints. Univariate regression will be conducted on each one of the clinically plausible potential confounders. We will enrol a total 136 patients, with the study duration of 2 years. This trial will commence recruitment on the 1 July 2019.
This trial protocol has achieved approval by the Austin Health Research Committee, HREC/17/Austin/596. This trial was prospectively registered with Australian New Zealand Clinical Trials Registry on the 10/05/2018 with a unique trial identifier U1111-1209-9072 and registration Number ACTRN12618000793213P. Findings of this study will be disseminated in peer-reviewed academic journals.
U1111-1209-9072, ACTRN12618000793213P.
开颅术后疼痛方案使用阿片类药物，而在该手术后，阿片类药物被认为镇痛效果欠佳。多模式镇痛成分较少。我们的零假设是，对于急性开颅术后疼痛的治疗，在使用常规静脉注射阿片类药物的基础上，舒马曲坦与安慰剂没有差异。
这是一项前瞻性单中心随机双盲安慰剂对照III期临床试验，比较在恢复区皮下注射舒马曲坦与安慰剂治疗开颅术后疼痛的效果。符合条件的成年患者（18岁及以上）在开颅术前进行识别。两组患者均将在恢复区护理人员按照标准化疼痛管理方案开始常规静脉注射阿片类镇痛的部位接受皮下注射。两组患者在接受研究药物注射后，均按照常规静脉注射阿片类药物进行进一步的疼痛管理。主要结局将包括两组患者在研究药物注射后60分钟在恢复区所经历的疼痛差异。开颅术后疼痛将在恢复区使用视觉模拟量表（VAS）定期测量。两组之间VAS上10毫米的最小临床重要差异将被视为具有统计学意义。我们将纳入选定的临床和患者报告结局作为次要终点。将对每个临床上可能的潜在混杂因素进行单变量回归分析。我们将总共招募136名患者，研究持续时间为2年。该试验将于2019年7月1日开始招募。
本试验方案已获得奥斯汀健康研究委员会（HREC/1...96）的批准。本试验于2018年5月10日在澳大利亚新西兰临床试验注册中心进行前瞻性注册，试验唯一标识符为U1111-1209-9072，注册号为ACTRN12618000793213P。本研究结果将在同行评审的学术期刊上发表。
U1111-1209-9072，ACTRN12618000793213P。
