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Arthroplasty, Replacement, HipPhase 4NCT01536301

Oxycodone Versus Intravenous Morphine for Postoperative Analgesia After Hip Surgery

A Phase 4 study testing Oxycodone in people with Arthroplasty, Replacement, Hip, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Arthroplasty, Replacement, Hip
What is being tested?
Oxycodone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
246 participants
Where
2 sitesFrance
Study dates
Jun 2012to 15 Nov 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • CHU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, Gard, 30029

  • APHP - Groupe Hospitalier Pitié-Salpetrière

    Paris, 75013

Other trials in France

About this study

Official title: 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.

Being tested
Standard Care morphine hydrochloride, Oxycodone
Keywords
oxycodone, morphine, hip replacement, analgesia, post operative analgesia
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Care morphine hydrochlorideDrug

    Also called morphine hydrochloride

    Post-operative analgesia including morphine (patient controlled analgesia).

  • OxycodoneDrug

    Also called oxycodone hydrochloride

    Post-operative analgesia including oxycodone (patient controlled analgesia).

Study groups in NCT01536301
Study groupRoleWhat they receive
MorphineActive comparatorThe patients in this arm will have post-operative analgesia including morphine (patient controlled analgesia).
Receives: Drug: Standard Care morphine hydrochloride
OxycodoneExperimentalThe patients in this arm will have post operative analgesia including oxycodone (patient controlled analgesia).
Receives: Drug: Oxycodone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 hours

Secondary outcomes (28)

  1. Number of opioid boluses in the post-intervention surveillance room

    Measured: Day 1

  2. Time to obtain a VAS score < 30/100 (from the first administration; minutes)

    Measured: Day 1

  3. Length of stay in the post-intervention surveillance room (minutes)

    Measured: Day 1

  4. Total dose of opioids during the first 24 hours (mg)

    Measured: 24 hours

  5. Total number of opioid requestions (patient controlled analgesia = PCA)

    Measured: Day 1

  6. Total number of opioid requestions (patient controlled analgesia = PCA)

    Measured: Day 2

  7. Total number of opioid requestions (patient controlled analgesia = PCA)

    Measured: Day 3

  8. Total number of opioid requestions accepted / refused (PCA)

    Measured: Day 1

  9. Total number of opioid requestions accepted / refused (PCA)

    Measured: Day 2

  10. Total number of opioid requestions accepted / refused (PCA)

    Measured: Day 3

  11. Ramsay score

    Measured: Day 1

  12. Ramsay score

    Measured: Day 2

  13. Ramsay score

    Measured: Day 3

  14. Presence / absence of an overdose of morphine/oxycodone (Ramsay score > 4)

    Measured: Day 1

  15. Presence / absence of an overdose of morphine/oxycodone (Ramsay score> 4)

    Measured: Day 2

  16. Presence / absence of an overdose of morphine/oxycodone (Ramsay score> 4)

    Measured: Day 3

  17. Presence/absence of complications

    nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation

    Measured: Day 1

  18. Presence/absence of complications

    nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation

    Measured: Day 2

  19. Presence/absence of complications

    nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation

    Measured: Day 3

  20. Patient satisfaction, VAS scale

    Measured: Hospital discharge

  21. Patient satisfaction, VAS scale

    Measured: 4 months

  22. Pain while at rest at while moving (Visual Analog Scale)

    Measured: Day -1 (before intervention)

  23. Pain while at rest at while moving (Visual Analog Scale)

    Measured: Day 1

  24. Pain while at rest at while moving (Visual Analog Scale)

    Measured: Day 2

  25. Pain while at rest at while moving (Visual Analog Scale)

    Measured: Day 3

  26. DN4 score

    Measured: Day -1 (before intervention)

  27. DN4 score

    Measured: 4 months

  28. Length of hospital stay (hours)

    Measured: Day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2012 (estimated)
  2. Study startJun 2012
  3. Primary completion15 Nov 2016
  4. Study completion15 Nov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
246 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01536301
Sponsor's protocol ID
LOCAL/2011/PC-02
Other IDs
2011-004140-22
Status last verified
Jan 2018
First submitted
16 Feb 2012
Last updated
19 Nov 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Cuvillon P, Alonso S, L'Hermite J, Reubrecht V, Zoric L, Vialles N, Luc Faillie J, Kouyoumdjian P, Boisson C, Raux M, Langeron O. Post-operative opioid-related adverse events with intravenous oxycodone compared to morphine: A randomized controlled trial. Acta Anaesthesiol Scand. 2021 Jan;65(1):40-46. doi: 10.1111/aas.13685. Epub 2020 Sep 27.

    PubMed 32790073

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oxycodone in people with Arthroplasty, Replacement, Hip, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite score of complications (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01536301, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.

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