Oxycodone Versus Intravenous Morphine for Postoperative Analgesia After Hip Surgery

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes
• Treatments: Morphine; Oxycodone

Criteria

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 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