Total Hip ArthroplastyPhase 3NEFARTHRONCT06349798
Early and Late Effects of Nefopam in Multimodal Analgesia After Total Hip Arthroplasty (NEFARTHRO)
A Phase 3 study testing Nefopam and NaCl 0.9% in people with Total Hip Arthroplasty, run by University Hospital, Tours at 7 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Nefopam and NaCl 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 546 participants
- Where
- 7 sitesFrance
- Study dates
- Apr 2024to Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites
Anaesthesia - Intensive care
Angers, 49933
Emmanuel RINEAU, MD, 02 41 35 39 51 ext. +33, Emmanuel.Rineau@chu-angers.fr
Emmanuel RINEAU, MD
Anaesthesia - Intensive care
Blois, 41016
Raphaël DARMON, MD, 02 54 55 66 33 ext. +33, darmonr@ch-blois.fr
Raphaël DARMON, MD
Anaesthesia - Intensive care
Chartres, 28018
Elias CHADDOUK, MD, 02 37 30 30 30 ext. +33, echaddouk@ch-chartres.fr
Elias CHADDOUK, MD
Anaesthesia - Intensive care
Nantes, 44000
Raphaël CINOTTI, MD, 02 53 48 22 30 ext. +33, Raphael.CINOTTI@chu-nantes.fr
Raphaël CINOTTI, MD
Anaesthesia - Intensive care
Orléans, 45067
Léa PARCOT, MD, 02 38 22 97 17 ext. +33, lea.pascot@chr-orleans.fr
Léa PARCOT, MD
Anaesthesia - Intensive care
Poitiers, 86021
Denis FRASCA, MD, 05 49 44 38 95 ext. +33, denis.frasca@univ-poitiers.fr
Denis FRASCA, MD
Anesthesia - intensive care
Tours, 37044
Francis REMERAND, MD, 02 47 47 84 80 ext. +33, F.REMERAND@chu-tours.fr
Francis REMERAND, MD
About this study
Official title: Early and Late Effects of Nefopam in Multimodal Analgesia After Total Hip Arthroplasty (NEFARTHRO): a Multicentric Randomized Controlled 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.
- Conditions
- Total Hip Arthroplasty
- Being tested
- Nefopam, NaCl 0.9%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NefopamDrug
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)
NefopamDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Nefopam "bolus" group | Experimental | Not described Receives: Drug: Nefopam |
| Nefopam "CIVI" group | Experimental | Not described Receives: Drug: Nefopam |
| Control group | Placebo comparator | Not described Receives: Drug: NaCl 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: at PACU, between PACU discharge and Hour 24, at Hour 24 and at Day 5 of hospital discharge
Time to return to walking.
Measured: At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6
Time to leave room.
Measured: At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6
Time to climb stairs.
Measured: At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6
Length of stay.
Measured: At Day 0 - Hour 0 up to Day 5 or at discharge
Time to abandon canes/crutches.
Measured: At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6
Opioid analgesic consumption between days 1 and 5 or at hospital discharge
Measured: at Hour 24 and up to day 5
Chronic pain at 6 months (at rest and walking) using a standardized phone questionnaire.
Measured: At Month 6
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).
Measured: At Hour 24 and Month 6
Incidence of all serious AEs during patient follow-up and non-serious AEs.
Measured: at Hour 24 and up to day 5
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.
Measured: at Hour 24 and up to day 5
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 546 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis REMERAND, MD PhD, Principal investigator, CHRU de Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349798
- Sponsor's protocol ID
- DR200177
- Acronym
- NEFARTHRO
- Status last verified
- Apr 2024
- First submitted
- 23 Jan 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early and Late Effects of Nefopam in Multimodal Analgesia After Total Hip Arthroplasty (NEFARTHRO): a Multicentric Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06349798
- Acronym / sponsor ID
- NEFARTHRO / DR200177
- Conditions
- Total Hip Arthroplasty
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 546 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Nefopam "bolus" group | Experimental | Drug: Nefopam |
| Nefopam "CIVI" group | Experimental | Drug: Nefopam |
| Control group | Placebo comparator | Drug: NaCl 0.9% |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- Septic or carcinological surgery
- Allergy to paracetamol, nefopam or NSAIDs
- Angle-closure glaucoma
- Prostate adenoma
- history of convulsion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nefopam20 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) | Drug | Nefopam "bolus" group |
| Nefopam20 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) | Drug | Nefopam "CIVI" group |
| 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) | Drug | Control group |
Primary outcome
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
12 secondary outcomes
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
Time to return to walking.
Time frame: At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6
Time to leave room.
Time frame: At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6
Time to climb stairs.
Time frame: At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6
Length of stay.
Time frame: At Day 0 - Hour 0 up to Day 5 or at discharge
Time to abandon canes/crutches.
Time frame: At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6
Opioid analgesic consumption between days 1 and 5 or at hospital discharge
Time frame: at Hour 24 and up to day 5
Chronic pain at 6 months (at rest and walking) using a standardized phone questionnaire.
Time frame: At Month 6
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).
Time frame: At Hour 24 and Month 6
Incidence of all serious AEs during patient follow-up and non-serious AEs.
Time frame: at Hour 24 and up to day 5
Incidence of patients with morphine side effects
Time frame: at Hour 24 and up to day 5
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.
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: No
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francis REMERAND, MD PhD principal investigator
CHRU de Tours
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nefopam and NaCl 0.9% in people with Total Hip Arthroplasty, run by University Hospital, Tours at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francis REMERAND, MD PhD (02.47.47.85.51 ext. +33, f.remerand@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: between Day 0 - Hour 0 and Hour 24 post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.