Clinical trial NCT01536301: Oxycodone Versus Intravenous Morphine for Postoperative Analgesia After Hip Surgery
Official title: Evaluation of Oxycodone Hydrochloride Versus Intravenous Morphine Hydrochloride for Postoperative Analgesia After Hip Prosthetic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthroplasty, Replacement, Hip
Keywords: oxycodone
morphine
hip replacement
analgesia
post operative analgesia
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-02-22
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Composite score of complications
timeFrame: 24 hours
Secondary outcomes:
measure: Number of opioid boluses in the post-intervention surveillance room
timeFrame: Day 1
measure: Time to obtain a VAS score < 30/100 (from the first administration; minutes)
timeFrame: Day 1
measure: Length of stay in the post-intervention surveillance room (minutes)
timeFrame: Day 1
measure: Total dose of opioids during the first 24 hours (mg)
timeFrame: 24 hours
measure: Total number of opioid requestions (patient controlled analgesia = PCA)
timeFrame: Day 1
measure: Total number of opioid requestions (patient controlled analgesia = PCA)
timeFrame: Day 2
measure: Total number of opioid requestions (patient controlled analgesia = PCA)
timeFrame: Day 3
measure: Total number of opioid requestions accepted / refused (PCA)
timeFrame: Day 1
measure: Total number of opioid requestions accepted / refused (PCA)
timeFrame: Day 2
measure: Total number of opioid requestions accepted / refused (PCA)
timeFrame: Day 3
measure: Ramsay score
timeFrame: Day 1
measure: Ramsay score
timeFrame: Day 2
measure: Ramsay score
timeFrame: Day 3
measure: Presence / absence of an overdose of morphine/oxycodone (Ramsay score > 4)
timeFrame: Day 1
measure: Presence / absence of an overdose of morphine/oxycodone (Ramsay score> 4)
timeFrame: Day 2
measure: Presence / absence of an overdose of morphine/oxycodone (Ramsay score> 4)
timeFrame: Day 3
measure: Presence/absence of complications
timeFrame: Day 1
measure: Presence/absence of complications
timeFrame: Day 2
measure: Presence/absence of complications
timeFrame: Day 3
measure: Patient satisfaction, VAS scale
timeFrame: Hospital discharge
measure: Patient satisfaction, VAS scale
timeFrame: 4 months
measure: Pain while at rest at while moving (Visual Analog Scale)
timeFrame: Day -1 (before intervention)
measure: Pain while at rest at while moving (Visual Analog Scale)
timeFrame: Day 1
measure: Pain while at rest at while moving (Visual Analog Scale)
timeFrame: Day 2
measure: Pain while at rest at while moving (Visual Analog Scale)
timeFrame: Day 3
measure: DN4 score
timeFrame: Day -1 (before intervention)
measure: DN4 score
timeFrame: 4 months
measure: Length of hospital stay (hours)
timeFrame: Day 3
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
state: Gard
city: Paris
country: France
facility: APHP - Groupe Hospitalier Pitié-Salpetrière
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Lana Zoric, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Philippe Cuvillon, MD
role: STUDY_DIRECTOR
References: