Thybo Kasper Højgaard, Hägi-Pedersen Daniel, Wetterslev Jørn, Dahl Jørgen Berg, Schrøder Henrik Morville, Bülow Hans Henrik, Bjørck Jan Gottfrid, Mathiesen Ole
Department of Anaesthesiology, Næstved Hospital, Ringstedgade 61, 4700, Næstved, Denmark.
Copenhagen Trial Unit, Rigshospitalet, Department 7812, Blegdamsvej 9, 2100, Copenhagen Ø, Denmark.
Trials. 2017 Jan 10;18(1):11. doi: 10.1186/s13063-016-1749-7.
Effective postoperative pain management is essential for the rehabilitation of the surgical patient. No 'gold standard' exists after total hip arthroplasty (THA) and combinations of different nonopioid medications are used with virtually no evidence for additional analgesic efficacy compared to monotherapy. The objective of this trial is to investigate the analgesic effects and safety of paracetamol and ibuprofen alone and in combination in different dosages after THA.
PANSAID is a placebo-controlled, parallel four-group, multicentre trial with centralised computer-generated allocation sequence and allocation concealment and with varying block size and stratification by site. Blinding of assessor, investigator, caregivers, patients and statisticians. Patients are randomised to four groups: (A) paracetamol 1 g × 4 and ibuprofen 400 mg × 4, (B) paracetamol 1 g × 4 and placebo, (C) placebo and ibuprofen 400 mg × 4 and (D) paracetamol 0.5 g × 4 and ibuprofen 200 mg. The two co-primary outcomes are 24-h consumption of morphine and number of patients with one or more serious adverse events within 90 days after surgery. Secondary outcomes are pain scores during mobilisation and at rest at 6 and 24 h postoperatively, and number of patients with one or more adverse events within 24 h postoperatively. Inclusion criteria are patients scheduled for unilateral, primary THA; age above 18 years; ASA status 1-3; BMI >18 and <40 kg/m; women must not be pregnant; and provision of informed consent. Exclusion criteria are patients who cannot cooperate with the trial; participation in another trial; patients who cannot understand/speak Danish; daily use of strong opioids; allergy against trial medication; contraindications against ibuprofen; alcohol and/or drug abuse. A total of 556 eligible patients are needed to detect a difference of 10 mg morphine i.v. the first 24 h postoperatively with a standard deviation of 20 mg and a family wise type 1 error rate of 0.025 (two-sided) and a type 2 error rate of 0.10 for the six possible comparisons of the four intervention groups.
We started recruiting patients in December 2015 and expect to finish in September 2017. Data analysis will be from September 2017 to October 2017 and manuscript submission ultimo 2017.
EudraCT: 2015-002239-16 (12/8-15); ClinicalTrials.gov: NCT02571361 . Registered on 7 October 2015.
有效的术后疼痛管理对于外科手术患者的康复至关重要。全髋关节置换术（THA）后不存在“金标准”，不同非阿片类药物联合使用，与单一疗法相比，几乎没有额外镇痛效果的证据。本试验的目的是研究对乙酰氨基酚和布洛芬单独及联合不同剂量使用在THA后的镇痛效果和安全性。
PANSAID是一项安慰剂对照、平行四组、多中心试验，采用集中计算机生成的分配序列和分配隐藏，分组大小不同且按地点分层。评估者、研究者、护理人员、患者和统计人员均采用盲法。患者被随机分为四组：（A）对乙酰氨基酚1g×4和布洛芬400mg×4；（B）对乙酰氨基酚1g×4和安慰剂；（C）安慰剂和布洛芬400mg×4；（D）对乙酰氨基酚0.5g×4和布洛芬200mg。两个共同主要结局是术后24小时吗啡消耗量和术后90天内发生1次或更多严重不良事件的患者数量。次要结局是术后6小时和24小时活动及休息时的疼痛评分，以及术后24小时内发生1次或更多不良事件的患者数量。纳入标准为计划进行单侧初次THA的患者；年龄18岁以上；美国麻醉医师协会（ASA）分级1 - 3级；体重指数（BMI）>18且<40kg/m²；女性必须未怀孕；并提供知情同意书。排除标准为不能配合试验的患者；参加另一项试验的患者；听不懂/不会说丹麦语的患者；日常使用强效阿片类药物的患者；对试验药物过敏的患者；布洛芬禁忌证患者；酗酒和/或药物滥用患者。为了在术后头24小时检测到静脉注射吗啡相差10mg的差异（标准差为20mg），且四个干预组的六种可能比较的家族性Ⅰ类错误率为0.025（双侧）、Ⅱ类错误率为0.10，共需要556名符合条件的患者。
我们于2015年12月开始招募患者，预计2017年9月结束。数据分析将于2017年9月至10月进行，2017年底提交论文。
欧洲临床试验数据库（EudraCT）：2015 - 002239 - 16（2015年8月12日）；美国国立医学图书馆临床试验注册库（ClinicalTrials.gov）：NCT02571361。于2015年10月7日注册。
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