Overview

This trial is active, not recruiting.

Condition arthroplasty, replacement, hip
Treatments standard care morphine hydrochloride, oxycodone
Phase phase 4
Sponsor Centre Hospitalier Universitaire de Nīmes
Start date June 2012
End date July 2016
Trial size 246 participants
Trial identifier NCT01536301, 2011-004140-22, LOCAL/2011/PC-02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
The patients in this arm will have post-operative analgesia including morphine (patient controlled analgesia).
standard care morphine hydrochloride morphine hydrochloride
Post-operative analgesia including morphine (patient controlled analgesia).
(Experimental)
The patients in this arm will have post operative analgesia including oxycodone (patient controlled analgesia).
oxycodone oxycodone hydrochloride
Post-operative analgesia including oxycodone (patient controlled analgesia).

Primary Outcomes

Measure
Composite score of complications
time frame: 24 hours

Secondary Outcomes

Measure
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
Presence/absence of complications
time frame: Day 2
Presence/absence of complications
time frame: Day 3
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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Evaluation of Oxycodone Hydrochloride Versus Intravenous Morphine Hydrochloride for Postoperative Analgesia After Hip Prosthetic Surgery
Principal investigator Lana Zoric, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Nīmes.