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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
246
Post-operative analgesia including morphine (patient controlled analgesia).
Post-operative analgesia including oxycodone (patient controlled analgesia).
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, Gard, France
APHP - Groupe Hospitalier Pitié-Salpetrière
Paris, France
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.
Time frame: 24 hours
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)
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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
nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation
Time frame: Day 1
Presence/absence of complications
nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation
Time frame: Day 2
Presence/absence of complications
nausea, vomiting, respiratory depression, pruritus, urinary retention, allergy to morphine or oxycodone, hallucinations, psychiatric disorders, constipation
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