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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

546 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2027-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Total Hip Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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Nefopam "bolus" group

Group Type EXPERIMENTAL

Nefopam

Intervention Type 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 "CIVI" group

Group Type EXPERIMENTAL

Nefopam

Intervention Type DRUG

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)

Control group

Group Type PLACEBO_COMPARATOR

NaCl 0.9%

Intervention Type 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)

Interventions

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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)

Intervention Type DRUG

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)

Intervention Type DRUG

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)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No