Oxycodone Versus Intravenous Morphine for Postoperative Analgesia After Hip Surgery

NCT ID: NCT01536301

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 246 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2016-11-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Morphine

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

Group Type: ACTIVE_COMPARATOR

Standard Care morphine hydrochloride

Intervention Type: DRUG

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

Oxycodone

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

Group Type: EXPERIMENTAL

Oxycodone

Intervention Type: DRUG

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

Interventions

Standard Care morphine hydrochloride

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

Intervention Type: DRUG

Oxycodone

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

Intervention Type: DRUG

Other Intervention Names

morphine hydrochloride; oxycodone hydrochloride

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lana Zoric, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Philippe Cuvillon, MD

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, France

APHP - Groupe Hospitalier Pitié-Salpetrière

Paris, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 32790073 (View on PubMed)

Other Identifiers

2011-004140-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LOCAL/2011/PC-02

Identifier Type: -

Identifier Source: org_study_id