Evaluation of Oxycodone Hydrochloride Versus Intravenous Morphine Hydrochloride for Postoperative Analgesia After Hip Prosthetic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 246
- 试验地点
- 2
- 主要终点
- Composite score of complications
研究概览
简要总结
The main objective is to demonstrate that postoperative analgesia by IV oxycodone (compared to morphine IV) reduces opioid-related adverse events (nausea, vomiting, pruritus, respiratory depression, urinary retention, allergies, hallucination) by 50% in adult patients operated on for prosthetic hip surgery.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is available for a 4 month follow-up
- •The patient weight between 50 and 100 kg
- •Patient scheduled for unilateral hip arthroplasty
- •Patient has creatinine clearance > 50 ml/min (Cockroft)
- •Patient with ASA-PS score of 1, 2 or 3 (American Society Anesthesiology - Physical Status)
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is pregnant, parturient, or breastfeeding
- •Patient with ASA score of 4
- •Patient has a known deficit in cytochrome P450
- •Uncontrolled epilepsy
- •Chronic alcoholism
- •Patient already taking opiate agonist on a long term basis (codeine, dextromoramide, dihydrocodeine, oxycodone po, morphine-like antitussif)
- •Patient already taking agonist-antagonists on a long term basis (buprenorphine, nalbuphine, pentazocine)
- •The patient is under treatment for liver inducing enzyme cytochrome P450: anti-infectives (e.g. rifampicin, rifabutin, nevirapine, griseofulvin), antiepileptic (phenobarbital, phenytoin)
- •the patient has an allergy to opiates
- •the patient has chronic renal insufficiency: creatinine clearance < 50 ml / min (Cockroft formula)
- •the patient has severe hepatic insufficiency(transaminase and/or alkaline phosphatase x 3/nal))
- •patient with porphyria, intracranial hypertension, a syndrome subocclusive or ileus
研究组 & 干预措施
Morphine
The patients in this arm will have post-operative analgesia including morphine (patient controlled analgesia).
干预措施: Standard Care morphine hydrochloride (Drug)
Oxycodone
The patients in this arm will have post operative analgesia including oxycodone (patient controlled analgesia).
干预措施: Oxycodone (Drug)
结局指标
主要结局
Composite score of complications
时间窗: 24 hours
The presence/absence of at least one of the following complications: nausea, vomiting, respiratory depression, pruritus (itch), urinary retention requiring evacuation (spontaneous voiding impossible despite bladder volume\> 400 ml measured by ultrasound), allergy (skin reaction, hallucination (perception without object). Drowsiness (Ramsay score) is not considered an adverse event within the primary endpoint.
次要结局
- Time to obtain a VAS score < 30/100 (from the first administration; minutes)(Day 1)
- Total number of opioid requestions (patient controlled analgesia = PCA)(Day 3)
- Total number of opioid requestions accepted / refused (PCA)(Day 3)
- Ramsay score(Day 3)
- Presence / absence of an overdose of morphine/oxycodone (Ramsay score > 4)(Day 1)
- Presence / absence of an overdose of morphine/oxycodone (Ramsay score> 4)(Day 3)
- Length of stay in the post-intervention surveillance room (minutes)(Day 1)
- Total dose of opioids during the first 24 hours (mg)(24 hours)
- Number of opioid boluses in the post-intervention surveillance room(Day 1)
- Presence/absence of complications(Day 3)
- Patient satisfaction, VAS scale(4 months)
- Pain while at rest at while moving (Visual Analog Scale)(Day 3)
- DN4 score(4 months)
- Length of hospital stay (hours)(Day 3)