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Completed

NCT Number: NCT01536301

Oxycodone Versus Intravenous Morphine for Postoperative Analgesia After Hip 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau, Nîmes, Gard, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Care morphine hydrochloride

Drug

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

Other names: morphine hydrochloride

Oxycodone

Drug

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

Other names: oxycodone hydrochloride

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Feb 22, 2012
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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