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Oxycodone Versus Intravenous Morphine for Postoperative Analgesia After Hip Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01536301
First received: February 16, 2012
Last updated: November 4, 2014
Last verified: November 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:


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

Primary Outcome Measures:
  • Composite score of complications [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
  • Time to obtain a VAS score < 30/100 (from the first administration; minutes) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Length of stay in the post-intervention surveillance room (minutes) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Total dose of opioids during the first 24 hours (mg) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Total number of opioid requestions (patient controlled analgesia = PCA) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Total number of opioid requestions (patient controlled analgesia = PCA) [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
  • Total number of opioid requestions (patient controlled analgesia = PCA) [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
  • Total number of opioid requestions accepted / refused (PCA) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Total number of opioid requestions accepted / refused (PCA) [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
  • Total number of opioid requestions accepted / refused (PCA) [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
  • Ramsay score [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  • Ramsay score [ Time Frame: Day 2 ] [ Designated as safety issue: Yes ]
  • Ramsay score [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
  • Presence / absence of an overdose of morphine/oxycodone (Ramsay score > 4) [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  • Presence / absence of an overdose of morphine/oxycodone (Ramsay score> 4) [ Time Frame: Day 2 ] [ Designated as safety issue: Yes ]
  • Presence / absence of an overdose of morphine/oxycodone (Ramsay score> 4) [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
  • Presence/absence of complications [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation

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

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

  • Patient satisfaction, VAS scale [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]
  • Patient satisfaction, VAS scale [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Pain while at rest at while moving (Visual Analog Scale) [ Time Frame: Day -1 (before intervention) ] [ Designated as safety issue: No ]
  • Pain while at rest at while moving (Visual Analog Scale) [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  • Pain while at rest at while moving (Visual Analog Scale) [ Time Frame: Day 2 ] [ Designated as safety issue: Yes ]
  • Pain while at rest at while moving (Visual Analog Scale) [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
  • DN4 score [ Time Frame: Day -1 (before intervention) ] [ Designated as safety issue: No ]
  • DN4 score [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Length of hospital stay (hours) [ Time Frame: Day 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 246
Study Start Date: June 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: December 2015 (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
Genders Eligible for Study:   Both
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

Contacts
Contact: Philippe Cuvillon, MD +33.(0)4.66.68.30.50 philippe.cuvillon@chu-nimes.fr
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 09, Gard, France, 30029
Sub-Investigator: Philippe Cuvillon, MD         
Principal Investigator: Lana Zoric, MD         
Sub-Investigator: Jacques Ripart, MD PhD         
Sub-Investigator: Joël L'Hermite, MD         
Sub-Investigator: Christophe Boisson, MD         
Sub-Investigator: Catherine Bourgaux, MD         
Sub-Investigator: Nathalie Vialles, MD         
APHP - Groupe Hospitalier Pitié-Salpetrière Recruiting
Paris, France, 75013
Principal Investigator: Olivier Langeron, MD PhD         
Sub-Investigator: Mathieu Raux, MD         
Sub-Investigator: Armelle Nicolas-Robin, MD         
Sub-Investigator: Frédéric Le Saché, MD         
Sub-Investigator: Sabine Roche, MD         
Sub-Investigator: Vanessa Reubrecht, MD         
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

No publications provided

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
Study First Received: February 16, 2012
Last Updated: November 4, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
oxycodone
morphine
hip replacement
analgesia
post operative analgesia

Additional relevant MeSH terms:
Morphine
Oxycodone
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014