Oxycodone Versus Intravenous Morphine for Postoperative Analgesia After Hip Surgery - Full Text View

Purpose

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.

Condition	Intervention	Phase
Arthroplasty, Replacement, Hip	Drug: Standard Care morphine hydrochloride Drug: Oxycodone	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Investigator, Outcomes Assessor Primary Purpose: Treatment
Official Title:	Evaluation of Oxycodone Hydrochloride Versus Intravenous Morphine Hydrochloride for Postoperative Analgesia After Hip Prosthetic Surgery

Resource links provided by NLM:

MedlinePlus related topics: Hip Replacement

Drug Information available for: Morphine hydrochloride Morphine sulfate Oxycodone Oxycodone hydrochloride

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:

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 Outcome Measures:

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 ]
nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation
Presence/absence of complications [ Time Frame: Day 2 ]
nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation
Presence/absence of complications [ Time Frame: Day 3 ]
nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation
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 ]


Estimated Enrollment:	246
Study Start Date:	June 2012
Estimated Study Completion Date:	May 2017
Primary Completion Date:	July 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Morphine The patients in this arm will have post-operative analgesia including morphine (patient controlled analgesia).	Drug: Standard Care morphine hydrochloride Post-operative analgesia including morphine (patient controlled analgesia). Other Name: morphine hydrochloride
Experimental: Oxycodone The patients in this arm will have post operative analgesia including oxycodone (patient controlled analgesia).	Drug: Oxycodone Post-operative analgesia including oxycodone (patient controlled analgesia). Other Name: oxycodone hydrochloride

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01536301

Locations


France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, Gard, France, 30029
APHP - Groupe Hospitalier Pitié-Salpetrière
Paris, France, 75013

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators


Principal Investigator:	Lana Zoric, MD	Centre Hospitalier Universitaire de Nîmes
Study Director:	Philippe Cuvillon, MD	Centre Hospitalier Universitaire de Nîmes

More Information


Responsible Party:	Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:	NCT01536301 History of Changes
Other Study ID Numbers:	LOCAL/2011/PC-02 2011-004140-22 ( EudraCT Number )
Study First Received:	February 16, 2012
Last Updated:	January 30, 2017

Keywords provided by Centre Hospitalier Universitaire de Nīmes:


oxycodone morphine hip replacement analgesia post operative analgesia

Additional relevant MeSH terms:


Morphine Oxycodone Analgesics, Opioid Narcotics Central Nervous System Depressants	Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 28, 2017