Early and Late Effects of Nefopam in Multimodal Analgesia After Total Hip Arthroplasty (NEFARTHRO)

NCT06349798 | Not Yet Recruiting Phase 3

• 1 other identifier: DR200177
• Study Type: interventional
• Target: 546
• Locations: 1 country
• Sites: 7

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.

Conditions

Total Hip Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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

• 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

Study Arms (3)

Nefopam "bolus" group

EXPERIMENTAL

Drug: Nefopam

Nefopam "CIVI" group

EXPERIMENTAL

Drug: Nefopam

Control group

PLACEBO COMPARATOR

Drug: NaCl 0.9%

Interventions

Nefopam DRUG

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)

Nefopam "bolus" group

NaCl 0.9% DRUG

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)

Control group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (7)

Anaesthesia - Intensive care

Angers, 49933, France

Location

Anaesthesia - Intensive care

Blois, 41016, France

Location

Anaesthesia - Intensive care

Chartres, 28018, France

Location

Anaesthesia - Intensive care

Nantes, 44000, France

Location

Anaesthesia - Intensive care

Orléans, 45067, France

Location

Anaesthesia - Intensive care

Poitiers, 86021, France

Location

Anesthesia - intensive care

Tours, 37044, France

Location

MeSH Terms

Interventions

Nefopam; Sodium Chloride

Intervention Hierarchy (Ancestors)

Oxazocines; Azocines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Francis REMERAND, MD PhD

  CHRU de Tours

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francis REMERAND, MD PhD

CONTACT

02.47.47.85.51; f.remerand@chu-tours.fr

Stellina AUGIS

CONTACT

02.47.47.46.38; stellina.augis@chu-tours.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, double-blind, randomized controlled trial in 3 parallel groups (placebo group, nefopam bolus group and nefopam Continuous Intra-Venous Infusion CIVI group).

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: April 5, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)