Oxycodone Versus Intravenous Morphine for Postoperative Analgesia After Hip Surgery
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ClinicalTrials.gov Identifier: NCT01536301 |
Recruitment Status
:
Completed
First Posted
: February 22, 2012
Last Update Posted
: January 3, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Arthroplasty, Replacement, Hip | Drug: Standard Care morphine hydrochloride Drug: Oxycodone | Phase 4 |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Morphine
The patients in this arm will have post-operative analgesia including morphine (patient controlled analgesia).
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Drug: Standard Care morphine hydrochloride
Post-operative analgesia including morphine (patient controlled analgesia).
Other Name: morphine hydrochloride
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Experimental: Oxycodone
The patients in this arm will have post operative analgesia including oxycodone (patient controlled analgesia).
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Drug: Oxycodone
Post-operative analgesia including oxycodone (patient controlled analgesia).
Other Name: oxycodone hydrochloride
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- 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.
- Number of opioid boluses in the post-intervention surveillance room [ Time Frame: Day 1 ]
- Time to obtain a VAS score < 30/100 (from the first administration; minutes) [ Time Frame: Day 1 ]
- Length of stay in the post-intervention surveillance room (minutes) [ Time Frame: Day 1 ]
- Total dose of opioids during the first 24 hours (mg) [ Time Frame: 24 hours ]
- Total number of opioid requestions (patient controlled analgesia = PCA) [ Time Frame: Day 1 ]
- Total number of opioid requestions (patient controlled analgesia = PCA) [ Time Frame: Day 2 ]
- Total number of opioid requestions (patient controlled analgesia = PCA) [ Time Frame: Day 3 ]
- Total number of opioid requestions accepted / refused (PCA) [ Time Frame: Day 1 ]
- Total number of opioid requestions accepted / refused (PCA) [ Time Frame: Day 2 ]
- Total number of opioid requestions accepted / refused (PCA) [ Time Frame: Day 3 ]
- Ramsay score [ Time Frame: Day 1 ]
- Ramsay score [ Time Frame: Day 2 ]
- Ramsay score [ Time Frame: Day 3 ]
- Presence / absence of an overdose of morphine/oxycodone (Ramsay score > 4) [ Time Frame: Day 1 ]
- Presence / absence of an overdose of morphine/oxycodone (Ramsay score> 4) [ Time Frame: Day 2 ]
- Presence / absence of an overdose of morphine/oxycodone (Ramsay score> 4) [ Time Frame: Day 3 ]
- Presence/absence of complications [ Time Frame: Day 1 ]nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation
- Presence/absence of complications [ Time Frame: Day 2 ]nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation
- Presence/absence of complications [ Time Frame: Day 3 ]nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation
- Patient satisfaction, VAS scale [ Time Frame: Hospital discharge ]
- Patient satisfaction, VAS scale [ Time Frame: 4 months ]
- Pain while at rest at while moving (Visual Analog Scale) [ Time Frame: Day -1 (before intervention) ]
- Pain while at rest at while moving (Visual Analog Scale) [ Time Frame: Day 1 ]
- Pain while at rest at while moving (Visual Analog Scale) [ Time Frame: Day 2 ]
- Pain while at rest at while moving (Visual Analog Scale) [ Time Frame: Day 3 ]
- DN4 score [ Time Frame: Day -1 (before intervention) ]
- DN4 score [ Time Frame: 4 months ]
- Length of hospital stay (hours) [ Time Frame: Day 3 ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01536301
France | |
CHU de Nîmes - Hôpital Universitaire Carémeau | |
Nîmes Cedex 09, Gard, France, 30029 | |
APHP - Groupe Hospitalier Pitié-Salpetrière | |
Paris, France, 75013 |
Principal Investigator: | Lana Zoric, MD | Centre Hospitalier Universitaire de Nîmes | |
Study Director: | Philippe Cuvillon, MD | Centre Hospitalier Universitaire de Nîmes |
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 Key Record Dates |
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 |