Oxycodone Versus Intravenous Morphine for Postoperative Analgesia After Hip Surgery

Phase 4

Completed

• Conditions: Arthroplasty, Replacement, Hip
• Interventions: Drug: Standard Care morphine hydrochloride; Drug: Oxycodone

• Registration Number: NCT01536301
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-02-21
• Study First Posted: 2012-02-22
• Study Start: 2012-06
• Primary Completion: 2016-07
• Study Completion: 2017-05
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-02
• Last Update Posted: 2018-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Morphine	Standard Care morphine hydrochloride	The patients in this arm will have post-operative analgesia including morphine (patient controlled analgesia).
Oxycodone	Oxycodone	The patients in this arm will have post operative analgesia including oxycodone (patient controlled analgesia).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Time to obtain a VAS score < 30/100 (from the first administration; minutes)	Day 1
Total number of opioid requestions (patient controlled analgesia = PCA)	Day 3
Total number of opioid requestions accepted / refused (PCA)	Day 3
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 3
Length of stay in the post-intervention surveillance room (minutes)	Day 1
Total dose of opioids during the first 24 hours (mg)	24 hours
Number of opioid boluses in the post-intervention surveillance room	Day 1
Length of hospital stay (hours)	Day 3
Presence/absence of complications	Day 3	nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation
Patient satisfaction, VAS scale	4 months
Pain while at rest at while moving (Visual Analog Scale)	Day 3
DN4 score	4 months

Trial Locations

Locations (2)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, Gard, France

APHP - Groupe Hospitalier Pitié-Salpetrière; 🇫🇷 Paris, France