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

Total Hip Arthroplasty Clinical Trial

— NEFARTHRO  

Official title:

Early and Late Effects of Nefopam in Multimodal Analgesia After Total Hip Arthroplasty (NEFARTHRO): a Multicentric Randomized Controlled Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06349798
• Other study ID #: DR200177
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 2024
• Est. completion date: April 2027

Study information

• Verified date: April 2024
• Source: University Hospital, Tours
• Contact: Francis REMERAND, MD PhD
• Phone: 02.47.47.85.51
• Email: f.remerand[@]chu-tours.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 546
• Est. completion date: April 2027
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Total Hip Arthroplasty

Intervention

Drug:
• Nefopam
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
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)
• NaCl 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)

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Time to return to walking.		At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6
Secondary	Time to leave room.		At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6
Secondary	Time to climb stairs.		At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6
Secondary	Length of stay.		At Day 0 - Hour 0 up to Day 5 or at discharge
Secondary	Time to abandon canes/crutches.		At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6
Secondary	Opioid analgesic consumption between days 1 and 5 or at hospital discharge		at Hour 24 and up to day 5
Secondary	Chronic pain at 6 months (at rest and walking) using a standardized phone questionnaire.		At Month 6
Secondary	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
Secondary	Incidence of all serious AEs during patient follow-up and non-serious AEs.		at Hour 24 and up to day 5
Secondary	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.	at Hour 24 and up to day 5
Secondary	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.	5 years