protocolSection identificationModule nctId: NCT06349798, orgStudyIdInfo id: DR200177, briefTitle: Early and Late Effects of Nefopam in Multimodal Analgesia After Total Hip Arthroplasty (NEFARTHRO), acronym: NEFARTHRO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University Hospital, Tours, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Total Hip Arthroplasty, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multicenter, double-blind, randomized controlled trial in 3 parallel groups (placebo group, nefopam bolus group and nefopam Continuous Intra-Venous Infusion CIVI group)., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: 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., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 546, type: ESTIMATED, armsInterventionsModule interventions name: Nefopam, interventions name: Nefopam, interventions name: NaCl 0.9%, outcomesModule primaryOutcomes measure: 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)., secondaryOutcomes measure: 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., secondaryOutcomes measure: Time to return to walking., secondaryOutcomes measure: Time to leave room., secondaryOutcomes measure: Time to climb stairs., secondaryOutcomes measure: Length of stay., secondaryOutcomes measure: Time to abandon canes/crutches., secondaryOutcomes measure: Opioid analgesic consumption between days 1 and 5 or at hospital discharge, secondaryOutcomes measure: Chronic pain at 6 months (at rest and walking) using a standardized phone questionnaire., secondaryOutcomes measure: 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)., secondaryOutcomes measure: Incidence of all serious AEs during patient follow-up and non-serious AEs., secondaryOutcomes measure: Incidence of patients with morphine side effects, secondaryOutcomes measure: 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., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anaesthesia - Intensive care, city: Angers, zip: 49933, country: France, contacts name: Emmanuel RINEAU, MD, role: CONTACT, phone: 02 41 35 39 51, phoneExt: +33, email: Emmanuel.Rineau@chu-angers.fr, contacts name: Emmanuel RINEAU, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.46667, lon: -0.55, locations facility: Anaesthesia - Intensive care, city: Blois, zip: 41016, country: France, contacts name: Raphaël DARMON, MD, role: CONTACT, phone: 02 54 55 66 33, phoneExt: +33, email: darmonr@ch-blois.fr, contacts name: Raphaël DARMON, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.58333, lon: 1.33333, locations facility: Anaesthesia - Intensive care, city: Chartres, zip: 28018, country: France, contacts name: Elias CHADDOUK, MD, role: CONTACT, phone: 02 37 30 30 30, phoneExt: +33, email: echaddouk@ch-chartres.fr, contacts name: Elias CHADDOUK, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.44685, lon: 1.48925, locations facility: Anaesthesia - Intensive care, city: Nantes, zip: 44000, country: France, contacts name: Raphaël CINOTTI, MD, role: CONTACT, phone: 02 53 48 22 30, phoneExt: +33, email: Raphael.CINOTTI@chu-nantes.fr, contacts name: Raphaël CINOTTI, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.21725, lon: -1.55336, locations facility: Anaesthesia - Intensive care, city: Orléans, zip: 45067, country: France, contacts name: Léa PARCOT, MD, role: CONTACT, phone: 02 38 22 97 17, phoneExt: +33, email: lea.pascot@chr-orleans.fr, contacts name: Léa PARCOT, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.90289, lon: 1.90389, locations facility: Anaesthesia - Intensive care, city: Poitiers, zip: 86021, country: France, contacts name: Denis FRASCA, MD, role: CONTACT, phone: 05 49 44 38 95, phoneExt: +33, email: denis.frasca@univ-poitiers.fr, contacts name: Denis FRASCA, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.58333, lon: 0.33333, locations facility: Anesthesia - intensive care, city: Tours, zip: 37044, country: France, contacts name: Francis REMERAND, MD, role: CONTACT, phone: 02 47 47 84 80, phoneExt: +33, email: F.REMERAND@chu-tours.fr, contacts name: Francis REMERAND, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.38333, lon: 0.68333, hasResults: False