PAracetamol and NSAID in Combination: A Randomised, Blinded, Parallel, 4-group Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 556
- 试验地点
- 6
- 主要终点
- Morphine consumption the first 24 hours postoperatively
研究概览
简要总结
Trial name: PAracetamol and NSAID in combination: A randomised, blinded, parallel, 4-group clinical trial
Trial acronym: PANSAID
Background: Effective postoperative pain management is essential for the well-being and rehabilitation of the surgical patient. No "gold standard" exists after total hip arthroplasty (THA) and combinations of different non-opioid medications are used with virtually no evidence for additional analgesic efficacy compared to monotherapy.
Objectives: The objective of this trial is to investigate the analgesic effects and safety of paracetamol and ibuprofen and their combination in different dosages after THA.
Intervention: Patients are randomised to 4 groups: A) paracetamol 1 g x 4 and ibuprofen 400 mg x 4; B) paracetamol 1 g x 4 and placebo (ibuprofen); C) placebo (paracetamol) and ibuprofen 400 mg x 4; and D) paracetamol 0,5 g x 4 and ibuprofen 200 mg.
Design: Placebo controlled, parallel 4-group, multicentre trial with adequate centralised computer-generated allocation sequence and allocation concealment with varying block size and stratification by site. Blinding of assessor, investigator, caregivers, patients, and statisticians.
Sample size: 556 eligible patients are needed to detect a difference of 10 mg morphine the first postoperative day with a standard deviation of 20 mg and a type 1 error rate of 0,004 (two-sided) and a type 2 error rate of 0,10.
详细描述
Trial name: PAracetamol and NSAID in combination: A randomised, blinded, parallel, 4-group clinical trial
Trial acronym: PANSAID
Background: Effective postoperative pain management is essential for the well-being and rehabilitation of the surgical patient. No "gold standard" exists after total hip arthroplasty (THA) and combinations of different non-opioid medications are used with virtually no evidence for additional analgesic efficacy compared to monotherapy.
Objectives: The objective of this trial is to investigate the analgesic effects and safety of paracetamol and ibuprofen and their combination in different dosages after THA.
Intervention: Patients are randomised to 4 groups: A) paracetamol 1 g x 4 and ibuprofen 400 mg x 4; B) paracetamol 1 g x 4 and placebo (ibuprofen); C) placebo (paracetamol) and ibuprofen 400 mg x 4; and D) paracetamol 0,5 g x 4 and ibuprofen 200 mg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for unilateral, primary Total Hip Arthroplasty (THA)
- •Age > 18
- •BMI > 18 and < 40
- •Women in the fertile age must have negative urine HCG pregnancy test
- •Patients who gave their written informed consent to participating in the trial after having fully understood the contents of the protocol and restrictions.
排除标准
- •Patients who cannot cooperate with the trial.
- •Concomitant participation in another trial
- •Patients who cannot understand or speak Danish.
- •Daily use of strong opioids (tramadol and codein are accepted)
- •Patients with allergy to the medicines used in the trial.
- •Contraindications against NSAID, for example previous ulcer, heart failure, liver failure, or renal failure (eGRF < 60 ml/kg/1,73m2), known thrombocytopenia (<100 mia/L)
- •Patients suffering from alcohol and/or drug abuse - based on the investigator's judgement.
研究组 & 干预措施
Treatment A:
Paracetamol 1g + ibuprofen 400 mg orally starting 1 hour before surgery and given with 6-hour intervals (+/- 1 hour) i.e. a total of 4 times the first 24 hours postoperative.
干预措施: Paracetamol (1g x 4) (Drug)
Treatment A:
Paracetamol 1g + ibuprofen 400 mg orally starting 1 hour before surgery and given with 6-hour intervals (+/- 1 hour) i.e. a total of 4 times the first 24 hours postoperative.
干预措施: Ibuprofen (400 mg x 4) (Drug)
Treatment B:
Paracetamol 1g + placebo orally starting 1 hour before surgery and given with 6-hour intervals (+/- 1 hour) i.e. a total of 4 times the first 24 hours postoperative.
干预措施: Paracetamol (1g x 4) (Drug)
Treatment B:
Paracetamol 1g + placebo orally starting 1 hour before surgery and given with 6-hour intervals (+/- 1 hour) i.e. a total of 4 times the first 24 hours postoperative.
干预措施: Placebo (x4) (Drug)
Treatment C:
Placebo + ibuprofen 400 mg orally starting 1 hour before surgery and given with 6-hour intervals (+/- 1 hour) i.e. a total of 4 times the first 24 hours postoperative.
干预措施: Ibuprofen (400 mg x 4) (Drug)
Treatment C:
Placebo + ibuprofen 400 mg orally starting 1 hour before surgery and given with 6-hour intervals (+/- 1 hour) i.e. a total of 4 times the first 24 hours postoperative.
干预措施: Placebo (x4) (Drug)
Treatment D:
Paracetamol 0,5 g + ibuprofen 200 mg orally starting 1 hour before surgery and given with 6-hour intervals (+/- 1 hour) i.e. a total of 4 times the first 24 hours postoperative.
干预措施: Paracetamol (0,5 g x 4) (Drug)
Treatment D:
Paracetamol 0,5 g + ibuprofen 200 mg orally starting 1 hour before surgery and given with 6-hour intervals (+/- 1 hour) i.e. a total of 4 times the first 24 hours postoperative.
干预措施: Ibuprofen (200 mg x 4) (Drug)
结局指标
主要结局
Morphine consumption the first 24 hours postoperatively
时间窗: 0-24 hours postoperatively
Total need for morphine administered as BOTH patient controlled analgesia (PCA) for the first 24 hours postoperatively AND supplemental morphine administered at the post-anaesthesia unit the first hour postoperatively. Bolus 2.0 mg; lockout: 10 min
Serious adverse events
时间窗: 0-90 days postoperatively
Serious adverse events, including death, within 90 days after surgery defined as SAE (according to ICH-GCP-guidelines) except "prolongation of hospitalisation"
次要结局
- Pain during movement at 6 hours postoperatively (visual analogue scale)(6 hours postoperatively)
- Pain during movement at 24 hours postoperatively (visual analogue scale)(24 hours postoperatively)
- Adverse events(0-24 hours postoperatively)
- Pain at rest at 6 hours postoperatively (visual analogue scale)(6 hours postoperatively)
- Pain at rest at 24 hours postoperatively (visual analogue scale)(24 hours postoperatively)
研究者
Daniel Hägi-Pedersen
Consultant
Naestved Hospital