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 range18 Years

SexALL

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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

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