Oxycodone Versus Intravenous Morphine for Postoperative Analgesia After Hip Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Arthroplasty, Replacement, Hip
• Intervention / Treatment: Drug: Standard Care morphine hydrochloride; Drug: Oxycodone

• Study Type: Interventional
• Enrollment (Actual): 246
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • APHP - Groupe Hospitalier Pitié-Salpetrière
  • Gard
    • Nîmes Cedex 09, Gard, France, 30029
      • CHU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Lana Zoric, MD, Centre Hospitalier Universitaire de Nîmes; Study Director: Philippe Cuvillon, MD, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: February 16, 2012
• First Submitted That Met QC Criteria: February 21, 2012
• First Posted (Estimate): February 22, 2012

Study Record Updates

• Last Update Posted (Actual): January 3, 2018
• Last Update Submitted That Met QC Criteria: January 2, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: morphine; hip replacement; analgesia; post operative analgesia; oxycodone
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine; Oxycodone
• Other Study ID Numbers: LOCAL/2011/PC-02; 2011-004140-22 (EudraCT Number)