Oxycodone Versus Intravenous Morphine for Postoperative Analgesia After Hip Surgery

NCT01536301 | Completed Phase 4 DMC

• 2 other identifiers: LOCAL/2011/PC-022011-004140-22
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 2

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.

Conditions

Arthroplasty, Replacement, Hip

Keywords

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

Outcome Measures

Primary Outcomes (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.

  24 hours

Secondary Outcomes (28)

• 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

Study Arms (2)

Morphine

ACTIVE COMPARATOR

The patients in this arm will have post-operative analgesia including morphine (patient controlled analgesia).

Drug: Standard Care morphine hydrochloride

Oxycodone

EXPERIMENTAL

The patients in this arm will have post operative analgesia including oxycodone (patient controlled analgesia).

Drug: Oxycodone

Interventions

Standard Care morphine hydrochloride DRUG

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

Also known as: morphine hydrochloride

Morphine

Oxycodone DRUG

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

Also known as: oxycodone hydrochloride

Oxycodone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• The patient is participating in another 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))

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

Location

APHP - Groupe Hospitalier Pitié-Salpetrière

Paris, 75013, France

Location

Related Publications (1)

• 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.

  PMID: 32790073 RESULT

MeSH Terms

Conditions

Agnosia

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Lana Zoric, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

• Philippe Cuvillon, MD

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: February 22, 2012
• Study Start: June 1, 2012
• Primary Completion: November 15, 2016
• Study Completion: November 15, 2016
• Last Updated: November 19, 2025

Record last verified: 2018-01

Locations

FR (2)