CompletedPhase 3

Opioid Free Anesthesia in Total Hip Arthroplasty

France80 participantsStarted 2022-02-03

Plain-language summary

Total hip arthroplasty (THA) is one of the most common orthopedic surgical procedure and is associated with severe pain in the immediate postoperative period, thus limiting early recovery. Postoperative pain management in THA requires multimodal analgesia, combining drugs and injection of a local anesthetic (LA). But, the best anesthesia strategy to provide optimal postoperative analgesia in THA remains controversial. Opioid free anesthesia could limit the episodes of hyperalgesia as well as tolerance and addiction to opioids. The hypothesis of this study is that an opioid free anesthesia using dexmedetomidine could improve analgesia after THA. The main objective of this monocenter, prospective, randomized, triple-blind, controlled trial is to assess the interest of opioid free anesthesia using dexmedetomidine on morphine consumption after THA.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 years and older, * Undergoing outpatient primary total hip arthroplasty under general anesthesia with laryngeal mask, * Consent for participation, * Affiliation to a social security system Exclusion Criteria: * Heart rate \< 60 bpm * Chronic pain syndrome requiring preoperative morphine use (class 3) * Contraindication for: paracetamol, ketoprofen, nefopam, oxycodone, propofol, ketamine, cisatracurium, sufentanyl, ropivacaine. * Contraindication for dexmedetomidine: hypersensitivity to the active substance or to any of the excipients, advanced cardiac block (grade 2 or 3) unless paced ; uncontrolled hypotension ; acute cerebrovascular conditions * Contraindication to laryngeal mask : old insulin-dependent diabetes, gastro-oesophageal reflux, morbid obesity (defined by BMI \> 35) * Pregnant or breastfeeding women * Women of child bearing potential without contraception (any contraceptive method used regularly and appropriately with a low failure rate: \<1% per year), * A mental or linguistic inability to understand the study, * Patient under protection of the adults (guardianship, curators or safeguard of justice), * Patient included or planning to be included in another clinical trial relating to medications

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postoperative analgesia, defined by the oxycodone consumption in the first 24 hours post-surgery

Timeframe: 24 hours

Trial details

NCT IDNCT05072704

SponsorCMC Ambroise Paré

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-02

View on ClinicalTrials.gov More Primary Total Hip Arthroplasty trials