Arthroplasty, Replacement, Hip | Oxycodone Versus Intravenous Morphine for Postoperative Analgesia After Hip Surgery
Arthroplasty, Replacement, Hip research study
What is the primary objective of this study?
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 is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Arthroplasty, Replacement, Hip
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Standard Care morphine hydrochloridePost-operative analgesia including morphine (patient controlled analgesia).
Drug:OxycodonePost-operative analgesia including oxycodone (patient controlled analgesia).
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
MorphineThe patients in this arm will have post-operative analgesia including morphine (patient controlled analgesia).
OxycodoneThe patients in this arm will have post operative analgesia including oxycodone (patient controlled analgesia).
Start Date: June 2012
Completed Date: May 2017
Phase: Phase 4
Primary Outcome: Composite score of complications
Secondary Outcome: Number of opioid boluses in the post-intervention surveillance room
Study sponsors, principal investigator, and references
Principal Investigator: Lana Zoric, MD
Lead Sponsor: Centre Hospitalier Universitaire de Nīmes