Oxycodone Versus Intravenous Morphine for Postoperative Analgesia After Hip Surgery

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Arthroplasty, Replacement, Hip	Drug: Standard Care morphine hydrochloride; Drug: Oxycodone	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	246 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Evaluation of Oxycodone Hydrochloride Versus Intravenous Morphine Hydrochloride for Postoperative Analgesia After Hip Prosthetic Surgery
Study Start Date :	June 2012
Actual Primary Completion Date :	July 2016
Actual Study Completion Date :	May 2017

Arms and Interventions

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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 Name: 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 Name: oxycodone hydrochloride

Outcome Measures

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Primary Outcome Measures :

1. Composite score of complications [ Time Frame: 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 :

1. Number of opioid boluses in the post-intervention surveillance room [ Time Frame: Day 1 ]
2. Time to obtain a VAS score < 30/100 (from the first administration; minutes) [ Time Frame: Day 1 ]
3. Length of stay in the post-intervention surveillance room (minutes) [ Time Frame: Day 1 ]
4. Total dose of opioids during the first 24 hours (mg) [ Time Frame: 24 hours ]
5. Total number of opioid requestions (patient controlled analgesia = PCA) [ Time Frame: Day 1 ]
6. Total number of opioid requestions (patient controlled analgesia = PCA) [ Time Frame: Day 2 ]
7. Total number of opioid requestions (patient controlled analgesia = PCA) [ Time Frame: Day 3 ]
8. Total number of opioid requestions accepted / refused (PCA) [ Time Frame: Day 1 ]
9. Total number of opioid requestions accepted / refused (PCA) [ Time Frame: Day 2 ]
10. Total number of opioid requestions accepted / refused (PCA) [ Time Frame: Day 3 ]
11. Ramsay score [ Time Frame: Day 1 ]
12. Ramsay score [ Time Frame: Day 2 ]
13. Ramsay score [ Time Frame: Day 3 ]
14. Presence / absence of an overdose of morphine/oxycodone (Ramsay score > 4) [ Time Frame: Day 1 ]
15. Presence / absence of an overdose of morphine/oxycodone (Ramsay score> 4) [ Time Frame: Day 2 ]
16. Presence / absence of an overdose of morphine/oxycodone (Ramsay score> 4) [ Time Frame: Day 3 ]
17. Presence/absence of complications [ Time Frame: Day 1 ]
    nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation
18. Presence/absence of complications [ Time Frame: Day 2 ]
    nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation
19. Presence/absence of complications [ Time Frame: Day 3 ]
    nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation
20. Patient satisfaction, VAS scale [ Time Frame: Hospital discharge ]
21. Patient satisfaction, VAS scale [ Time Frame: 4 months ]
22. Pain while at rest at while moving (Visual Analog Scale) [ Time Frame: Day -1 (before intervention) ]
23. Pain while at rest at while moving (Visual Analog Scale) [ Time Frame: Day 1 ]
24. Pain while at rest at while moving (Visual Analog Scale) [ Time Frame: Day 2 ]
25. Pain while at rest at while moving (Visual Analog Scale) [ Time Frame: Day 3 ]
26. DN4 score [ Time Frame: Day -1 (before intervention) ]
27. DN4 score [ Time Frame: 4 months ]
28. Length of hospital stay (hours) [ Time Frame: Day 3 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:	NCT01536301 History of Changes
Other Study ID Numbers:	LOCAL/2011/PC-02; 2011-004140-22 ( EudraCT Number )
First Posted:	February 22, 2012
Last Update Posted:	January 3, 2018
Last Verified:	January 2018

Keywords provided by Centre Hospitalier Universitaire de Nīmes:

oxycodone; morphine; hip replacement; analgesia; post operative analgesia

Additional relevant MeSH terms:

Morphine; Oxycodone; Analgesics, Opioid; Narcotics; Central Nervous System Depressants	Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents