Clinical trial NCT06349798: Early and Late Effects of Nefopam in Multimodal Analgesia After Total Hip Arthroplasty (NEFARTHRO)
Official title: Early and Late Effects of Nefopam in Multimodal Analgesia After Total Hip Arthroplasty (NEFARTHRO): a Multicentric Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Total Hip Arthroplasty
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 546
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
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).
timeFrame: between Day 0 - Hour 0 and Hour 24 post surgery
Secondary outcomes:
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.
timeFrame: at PACU, between PACU discharge and Hour 24, at Hour 24 and at Day 5 of hospital discharge
measure: Time to return to walking.
timeFrame: At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6
measure: Time to leave room.
timeFrame: At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6
measure: Time to climb stairs.
timeFrame: At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6
measure: Length of stay.
timeFrame: At Day 0 - Hour 0 up to Day 5 or at discharge
measure: Time to abandon canes/crutches.
timeFrame: At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6
measure: Opioid analgesic consumption between days 1 and 5 or at hospital discharge
timeFrame: at Hour 24 and up to day 5
measure: Chronic pain at 6 months (at rest and walking) using a standardized phone questionnaire.
timeFrame: At Month 6
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).
timeFrame: At Hour 24 and Month 6
measure: Incidence of all serious AEs during patient follow-up and non-serious AEs.
timeFrame: at Hour 24 and up to day 5
measure: Incidence of patients with morphine side effects
timeFrame: at Hour 24 and up to day 5
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.
timeFrame: 5 years
Other outcomes:
Locations:
city: Angers
country: France
facility: Anaesthesia - Intensive care
city: Blois
country: France
facility: Anaesthesia - Intensive care
city: Chartres
country: France
facility: Anaesthesia - Intensive care
city: Nantes
country: France
facility: Anaesthesia - Intensive care
city: Orléans
country: France
facility: Anaesthesia - Intensive care
city: Poitiers
country: France
facility: Anaesthesia - Intensive care
city: Tours
country: France
facility: Anesthesia - intensive care
Study officials:
affiliation: CHRU de Tours
name: Francis REMERAND, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: