NEFARTHRO is a multicentric randomized controlled trial comparing the effects of discontinuous infusions of nefopam (bolus) versus continuous infusion of intravenous nefopam (via an infusion pump) versus placebo on the opioid-request during the first 24 hours following a Total Hip arthroplasty, as part of multimodal analgesia including at least paracetamol and a Non-Steroidal Anti-Inflammatory Drug (NSAID). The primary endpoint is cumulative morphine consumption for the first postoperative 24 hours, expressed in mg of iv equivalent morphine, including titration in the Post Anesthesia Care Unit (PACU). Patients will be followed during 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
546
20 mg nefopam in 50 ml of saline, during a 30 min infusion, before end of procedure, then a similer bolus every 4 h for 24 h (6 injections in total) + continuous intravenous infusion of placebo (2 mL/h saline)
20 mg nefopam in 50 ml of saline, during a 30 min infusion, before end of procedure, then a bolus of placebo every 4 h for 24 h (6 injections in total) + continuous infusion of 100 mg nefopam over 24 h (in 48 mL saline, 2 mL/h)
50 ml of saline, during a 30 min infusion, before end of procedure, followed by a bolus of placebo every 4 hours for 24 hours (6 injections in all) + continuous infusion of placebo (2 mL/h of physiological saline)
Anaesthesia - Intensive care
Angers, France
Anaesthesia - Intensive care
Blois, France
Anaesthesia - Intensive care
Chartres, France
Anaesthesia - Intensive care
Nantes, France
Anaesthesia - Intensive care
Orléans, France
Anaesthesia - Intensive care
Poitiers, France
Anesthesia - intensive care
Tours, France
Cumulative morphine consumption from the end of surgery (Day 0 - Hour 0) to the first 24 hours after surgery, expressed in mg of intravenous morphine (including titration in the Post-Anesthesia care Unit PACU).
Time frame: between Day 0 - Hour 0 and Hour 24 post surgery
Maximum self-assessed pain using the Numeric Rating Scale ranging from 0 (no pain) to 10 (maximum pain) at rest in the PACU, at rest and on walking between PACU discharge and Hour 24, at Hour 24, and at hospital discharge.
Time frame: at PACU, between PACU discharge and Hour 24, at Hour 24 and at Day 5 of hospital discharge
Time to return to walking.
Time frame: At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6
Time to leave room.
Time frame: At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6
Time to climb stairs.
Time frame: At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6
Length of stay.
Time frame: At Day 0 - Hour 0 up to Day 5 or at discharge
Time to abandon canes/crutches.
Time frame: At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6
Opioid analgesic consumption between days 1 and 5 or at hospital discharge
Time frame: at Hour 24 and up to day 5
Chronic pain at 6 months (at rest and walking) using a standardized phone questionnaire.
Time frame: At Month 6
Neuropathic pain score (DN2)The DN2 is a simplified version of the DN4, with 7 items: burning, painful cold, electric shocks, tingling, pins and needles, numbness, itching (scored 0=absent, 1=present).
Time frame: At Hour 24 and Month 6
Incidence of all serious AEs during patient follow-up and non-serious AEs.
Time frame: at Hour 24 and up to day 5
Incidence of patients with morphine side effects
Incidence of patients with morphine side effects: nausea, vomiting, use of anti-nausea medication, pruritus requiring modification of management, urinary retention, use of urinary antispasmodics or urethral catheterization/suprapubic catheter, or abnormal drowsiness.
Time frame: at Hour 24 and up to day 5
Financial impact of spreading the recommended strategy following the results of the clinical study, estimated per year and over a 5-year period, from the point of view of the French Health Insurance and from the hospital perspective.
These financial impacts will be estimated using budget impact models.
Time frame: 5 years
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