Oxycodone Versus Intravenous Morphine for Postoperative Analgesia After Hip Surgery

Arthroplasty, Replacement, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01536301
• Other study ID #: LOCAL/2011/PC-02
• Secondary ID: 2011-004140-22
• Status: Completed
• Phase: Phase 4
• First received: February 16, 2012
• Last updated: January 2, 2018
• Start date: June 2012
• Est. completion date: May 2017

Study information

• Verified date: January 2018
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: May 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

Intervention

Drug:
• Standard Care morphine hydrochloride
Post-operative analgesia including morphine (patient controlled analgesia).
• Oxycodone
Post-operative analgesia including oxycodone (patient controlled analgesia).

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09	Gard
France	APHP - Groupe Hospitalier Pitié-Salpetrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of opioid boluses in the post-intervention surveillance room		Day 1
Secondary	Time to obtain a VAS score < 30/100 (from the first administration; minutes)		Day 1
Secondary	Length of stay in the post-intervention surveillance room (minutes)		Day 1
Secondary	Total dose of opioids during the first 24 hours (mg)		24 hours
Secondary	Total number of opioid requestions (patient controlled analgesia = PCA)		Day 1
Secondary	Total number of opioid requestions (patient controlled analgesia = PCA)		Day 2
Secondary	Total number of opioid requestions (patient controlled analgesia = PCA)		Day 3
Secondary	Total number of opioid requestions accepted / refused (PCA)		Day 1
Secondary	Total number of opioid requestions accepted / refused (PCA)		Day 2
Secondary	Total number of opioid requestions accepted / refused (PCA)		Day 3
Secondary	Ramsay score		Day 1
Secondary	Ramsay score		Day 2
Secondary	Ramsay score		Day 3
Secondary	Presence / absence of an overdose of morphine/oxycodone (Ramsay score > 4)		Day 1
Secondary	Presence / absence of an overdose of morphine/oxycodone (Ramsay score> 4)		Day 2
Secondary	Presence / absence of an overdose of morphine/oxycodone (Ramsay score> 4)		Day 3
Secondary	Presence/absence of complications	nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation	Day 1
Secondary	Presence/absence of complications	nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation	Day 2
Secondary	Presence/absence of complications	nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation	Day 3
Secondary	Patient satisfaction, VAS scale		Hospital discharge
Secondary	Patient satisfaction, VAS scale		4 months
Secondary	Pain while at rest at while moving (Visual Analog Scale)		Day -1 (before intervention)
Secondary	Pain while at rest at while moving (Visual Analog Scale)		Day 1
Secondary	Pain while at rest at while moving (Visual Analog Scale)		Day 2
Secondary	Pain while at rest at while moving (Visual Analog Scale)		Day 3
Secondary	DN4 score		Day -1 (before intervention)
Secondary	DN4 score		4 months
Secondary	Length of hospital stay (hours)		Day 3