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Can a smart monitor reduce opioid use during hip surgery?

NCT ID NCT07747142

Symptom relief Sponsor: Pole Sante Oreliance, Polyclinique des Longues Allees Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This study compares two ways of managing pain during total hip replacement surgery: one uses a device called CARDEAN® to guide the amount of opioid painkiller given, and the other avoids opioids entirely. The goal is to see if the CARDEAN-guided method is just as good at controlling pain after surgery as the opioid-free method. The trial involves 140 adults scheduled for hip replacement under general anesthesia, and it will measure how much morphine they need in the first 24 hours after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CARDEAN®-guided titrated opioid-sparing anesthesia (using sufentanil) compared to opioid-free anesthesia
What this could lead to
If successful, this approach could offer a way to manage pain during hip replacement surgery with fewer opioids, potentially leading to faster recovery and earlier discharge from the hospital.
What could go wrong
This is a single-center trial with a modest number of participants, and the results may not apply to all patients or hospitals. There is also a risk that the CARDEAN-guided method might not be as effective as opioid-free anesthesia in controlling pain after surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Men and women * Patient aged at least 18 years * Signed informed consent * American Society of Anesthesiologists (ASA) Class 1 to 3 * Scheduled total hip arthroplasty under general anesthesia (anterior or lateral approach) with local analgesic infiltration performed by the surgeon at the end of the procedure * Affiliated with or a beneficiary of a social security scheme. Exclusion Criteria: * ASA Class 4 or 5 * Emergency hip surgery * Indication for an anesthesia technique other than general anesthesia (patient preference, benefit-risk ratio, etc.) * Permanent cardiac arrhythmia or permanent cardiac pacing (invalid CARDEAN® index) * Resting bradycardia \< 50 bpm * Second- or third-degree atrioventricular block * Chronic opioid user * Refusal of consent * Patient unable to read, write, or understand French * Vulnerable patient as defined by Article L1121-6 of the Public Health Code (CSP) * Adult patient under guardianship, curatorship, or judicial protection * Patient unable to personally provide consent as defined by Article L.1121-8 of the CSP, or an adult under legal protection * Pregnant or breastfeeding woman as defined by Article L1121-5 of the CSP

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Total hip arthroplasty (THA)

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Pole Sante Oreliance, Polyclinique des Longues Allees

    Saran, 45770, France

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