Oxycodone Versus Intravenous Morphine for Postoperative Analgesia After Hip Surgery
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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 |
- 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.
- 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: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (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 |
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| 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 |
| 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 | Not yet 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 | |
| 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: | March 26, 2013 |
| 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, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotics |
ClinicalTrials.gov processed this record on May 19, 2013