Postoperative Pain Treatment in Total Hip Arthroplasty A Randomized Double-blinded Placebo-controlled Study to Assess the Effect of Local Analgesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pain score
研究概览
简要总结
The purpose of this study is to determine whether the investigator standardized pain treatment plus local pain treatment is more effective than the investigator standardized pain treatment plus placebo in total hip arthroplasty.
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 an uncemented unilateral Total Hip Replacement because of osteoarthritis
- •Willingness and possibility to follow the instructions of the study
- •18 years or older
- •written informed consent and authority after it has been read and understood.
排除标准
- •Operation with anterior approach or using navigation
- •Do not understand or speech danish
- •Can not use the pain-score Numerical Rating Scale (NRS)
- •Special indications for Total Hip Replacement
- •Anaesthetized in general anaesthesia where a tube is demanded
- •Daily use of strong opioids, based on the investigators assessment
- •Fertile women
- •ASA-score: 3 and 4
- •Known allergy against the standardized pain treatment, the study drugs and placebo, Ropivacaine, Ketorolac, Adrenalin.
- •Treatment with Lithium, Dihydroergotamin, full anticoagulant treatment or MAO-inhibitor
- •Following illness:
- •Active gastric ulcer or earlier gastrointestinal bleeding, ulceration or perforation of any kind.
- •Suspicions of manifest gastrointestinal bleeding and/or cerebrovascular bleeding
- •Haemorrhagic diathesis
- •Coagulation disorder
- •Severe thrombocytopenia
- •Severe heart insufficiency
- •Severe risk of postoperative bleeding or delayed haemostatic
- •Myocardium hypertrophy or ischaemic heart disease
- •Hypertension
- •Hypovolemics
- •Anhydration
- •angiooedema
- •Bronchospasm
- •Severe liver insufficiency
- •Rhinostenosis because of polyostotic
- •Narrow-angled glaucoma
- •Phaeochromocytoma
- •Low plasm-potassium
- •Thyreotoxicosis
研究组 & 干预措施
A
This group receive local analgesic with Ropivacaine 200 mg, Ketorolac 30 mg and Adrenaline 1 mg 10 and 22 hours after the operation. The medicine solution is given in a catheter, wich is placed in the hip at the end of the operation.
干预措施: Ropivacaine, Ketorolac and Adrenalin (Drug)
B
This group receive Placebo 10 and 22 hours after the operation. The Placebo is given in a catheter, wich is placed in the hip at the end of the operation.
干预措施: Placebo (Drug)
结局指标
主要结局
Pain score
时间窗: 24 hours
Opioid Consumption
时间窗: 24 hours
次要结局
- Pain score(7 days)
- Opioid consumption(3 days)
- Postoperative Nausea and Vomiting (PONV)(3 days)
- Fatigue(3 days)
- Physical function(2 month)
研究者
Per Kjaersgaard-Andersen
Per Kjaersgaard-Andersen MD
Vejle Hospital