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

ConditionTotal Hip Arthroplasty
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity Hospital, Tours

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Septic or carcinological surgery

Allergy to paracetamol, nefopam or NSAIDs

Angle-closure glaucoma

Prostate adenoma

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

    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)

  • 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)

Treatment groups

546 Participants
are divided into 3 treatment groups
Group A: Nefopam "bolus" groupExperimental treatment 1 intervention
Group B: Nefopam "CIVI" groupExperimental treatment 1 intervention
Group C: Control groupPlacebo comparator 1 intervention

Trial outcomes

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).

Time frame
between Day 0 - Hour 0 and Hour 24 post surgery

Secondary outcomes

1

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.

Time frame
at PACU, between PACU discharge and Hour 24, at Hour 24 and at Day 5 of hospital discharge
2

Time to return to walking.

Time frame
At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6
3

Time to leave room.

Time frame
At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6
4

Time to climb stairs.

Time frame
At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Tours

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: