Arthroplasty, Replacement, Hip
Conditions
Keywords
oxycodone, morphine, hip replacement, analgesia, post operative analgesia
Brief 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.
Interventions
DRUGStandard Care morphine hydrochloride
Post-operative analgesia including morphine (patient controlled analgesia).
DRUGOxycodone
Post-operative analgesia including oxycodone (patient controlled analgesia).
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite score of complications | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to obtain a VAS score < 30/100 (from the first administration; minutes) | Day 1 | — |
| Length of stay in the post-intervention surveillance room (minutes) | Day 1 | — |
| Total dose of opioids during the first 24 hours (mg) | 24 hours | — |
| Total number of opioid requestions (patient controlled analgesia = PCA) | Day 1 | — |
| Total number of opioid requestions accepted / refused (PCA) | Day 1 | — |
| Ramsay score | Day 1 | — |
| Number of opioid boluses in the post-intervention surveillance room | Day 1 | — |
| Presence / absence of an overdose of morphine/oxycodone (Ramsay score> 4) | Day 2 | — |
| Presence/absence of complications | Day 1 | nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation |
| Patient satisfaction, VAS scale | Hospital discharge | — |
| Pain while at rest at while moving (Visual Analog Scale) | Day -1 (before intervention) | — |
| DN4 score | Day -1 (before intervention) | — |
| Length of hospital stay (hours) | Day 3 | — |
| Presence / absence of an overdose of morphine/oxycodone (Ramsay score > 4) | Day 1 | — |
Countries
France
Outcome results
None listed