Oxycodone Versus Intravenous Morphine for Postoperative Analgesia After Hip Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Oxycodone Hydrochloride Versus Intravenous Morphine Hydrochloride for Postoperative Analgesia After Hip Prosthetic Surgery

Conditions
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Arthroplasty, Replacement, Hip

Intervention / Treatment
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* Drug: Standard Care morphine hydrochloride
* Drug: Oxycodone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Morphine<br>The patients in this arm will have post-operative analgesia including morphine (patient controlled analgesia). | Drug: Standard Care morphine hydrochloride<br>* Post-operative analgesia including morphine (patient controlled analgesia).<br>* Other names: morphine hydrochloride;|
| Experimental: Oxycodone<br>The patients in this arm will have post operative analgesia including oxycodone (patient controlled analgesia). | Drug: Oxycodone<br>* Post-operative analgesia including oxycodone (patient controlled analgesia).<br>* Other names: oxycodone hydrochloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite score of complications | 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. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of opioid boluses in the post-intervention surveillance room |  | Day 1 | 
| 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 (patient controlled analgesia = PCA) |  | Day 2 | 
| Total number of opioid requestions (patient controlled analgesia = PCA) |  | Day 3 | 
| Total number of opioid requestions accepted / refused (PCA) |  | Day 1 | 
| Total number of opioid requestions accepted / refused (PCA) |  | Day 2 | 
| Total number of opioid requestions accepted / refused (PCA) |  | Day 3 | 
| Ramsay score |  | Day 1 | 
| Ramsay score |  | Day 2 | 
| Ramsay score |  | Day 3 | 
| Presence / absence of an overdose of morphine/oxycodone (Ramsay score > 4) |  | Day 1 | 
| Presence / absence of an overdose of morphine/oxycodone (Ramsay score> 4) |  | Day 2 | 
| Presence / absence of an overdose of morphine/oxycodone (Ramsay score> 4) |  | Day 3 | 
| Presence/absence of complications | nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation | Day 1 | 
| Presence/absence of complications | nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation | Day 2 | 
| Presence/absence of complications | nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation | Day 3 | 
| Patient satisfaction, VAS scale |  | Hospital discharge | 
| Patient satisfaction, VAS scale |  | 4 months | 
| Pain while at rest at while moving (Visual Analog Scale) |  | Day -1 (before intervention) | 
| Pain while at rest at while moving (Visual Analog Scale) |  | Day 1 | 
| Pain while at rest at while moving (Visual Analog Scale) |  | Day 2 | 
| Pain while at rest at while moving (Visual Analog Scale) |  | Day 3 | 
| DN4 score |  | Day -1 (before intervention) | 
| DN4 score |  | 4 months | 
| Length of hospital stay (hours) |  | Day 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxycodone, morphine, hip replacement, analgesia, post operative analgesia