Total Hip Arthroplasty
Conditions
Brief summary
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.
Interventions
DRUGNefopam
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)
DRUGNaCl 0.9%
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)
Sponsors
University Hospital, Tours
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Patient, investigator and outcome assessor will be blind., A nurse anesthetist who will not be involved in the follow up of the patient will receive the kit and prepare the syringes.
Intervention model description
Multicenter, double-blind, randomized controlled trial in 3 parallel groups (placebo group, nefopam bolus group and nefopam Continuous Intra-Venous Infusion CIVI group).
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patient aged ≥ 18 years, fluent in French. * Planned primary or secondary total hip replacement, regardless of surgical approach or type of prosthesis. * Receiving paracetamol and ketoprofen postoperatively. * Under general anesthesia or spinal anesthesia (without intrathecal morphine). * Participant affiliated to a social security scheme * Participant's free, informed and written consent
Exclusion criteria
* Septic or carcinological surgery * Allergy to paracetamol, nefopam or NSAIDs * Angle-closure glaucoma * Prostate adenoma * history of convulsion * Nocturnal pollakiuria in men with more than two risings per night * Severe hepatic (Child C) or cardiac insufficiency (LVEF \< 30%) * Renal insufficiency with creatinine clearance \< 50 mL/ min according to Cockroft's formula * Active peptic ulcer or history of digestive bleeding or peptic perforation * Patients with opioid treatment for chronic pain other than coxarthrosis (fentanyl, oral morphine \> 50mg/d or equivalent) * Protected patient: safeguard of justice, guardianship or curatorship * Incomprehension or inability to use a numerical rating scale or to self-assess/manage pain * Pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | between Day 0 - Hour 0 and Hour 24 post surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to return to walking. | At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6 | — |
| Time to leave room. | At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6 | — |
| Time to climb stairs. | At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6 | — |
| Length of stay. | At Day 0 - Hour 0 up to Day 5 or at discharge | — |
| Time to abandon canes/crutches. | At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6 | — |
| 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. | at PACU, between PACU discharge and Hour 24, at Hour 24 and at Day 5 of hospital discharge | — |
| Chronic pain at 6 months (at rest and walking) using a standardized phone questionnaire. | 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). | At Hour 24 and Month 6 | — |
| Incidence of all serious AEs during patient follow-up and non-serious AEs. | at Hour 24 and up to day 5 | — |
| Incidence of patients with morphine side effects | at Hour 24 and up to day 5 | 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. |
| 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. | 5 years | These financial impacts will be estimated using budget impact models. |
| Opioid analgesic consumption between days 1 and 5 or at hospital discharge | at Hour 24 and up to day 5 | — |
Countries
France
Contacts
Primary ContactFrancis REMERAND, MD PhD
Backup ContactStellina AUGIS
Outcome results
None listed