Oxycodone Versus Intravenous Morphine for Postoperative Analgesia After Hip Surgery (NCT01536301) | Clinical Trial Compass
CompletedPhase 4
Oxycodone Versus Intravenous Morphine for Postoperative Analgesia After Hip Surgery
France246 participantsStarted 2012-06
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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 m…