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.
In the pre-anaesthesia room, after the implementation of classical monitoring and a peripheral venous catheter, all patients will receive an antibioprophylaxis according to SFAR (French Society of Anesthesia \& Intensive Care Medecine) recommendations and injection of 10 mg of IV dexamethasone. The patients will be then randomized in 2 groups: Control group: * Pre-operative normal saline infusion 100 ml over 30 minutes * Injection of sufentanil 10 µg in normal saline 2 ml on induction of anesthesia If needed after incision : * Per-operative normal saline infusion 100 ml * Per-operative injection of sufentanil 5 µg in normal saline 1 ml OFA group (experimental group): * Pre-operative dexmedetomidine infusion 1 µg/kg in normal saline 100 ml over 30 minutes * Injection of normal saline 2 ml on induction of anesthesia If needed after incision : * Per-operative dexmedetomidine infusion 0.4 µg/kg in normal saline 100 ml * Per-operative injection of normal saline 1 ml In the operating room, general anesthesia will be induced by intravenous ketamine (0.4 mg/kg) + propofol (3 mg/kg) +/- cisatracurium (0.1 mg/kg) for the introduction of laryngeal mask airway. Anesthesia will be maintained with propofol. Postoperative analgesia protocol : * Multimodal analgesia will be instituted during surgery by the administration of paracetamol (1 g), nefopam (20 mg) and ketoprofen (100 mg) and the infiltration of the surgical wound with 100 ml of ropivacaine 0.2%. * In post-anesthesia care unit (PACU): oxycodone titration if NRS (pain score) \>3 according to the centre's usual care. * In ward and at home: systematic per os analgesia with paracetamol (1 g, 4 times a day) and ibuprofen (400 mg, 3 times a day); oxycodone (10 mg, lockout interval: 4 h) if NRS (pain score) \>3.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Pre-operative injection of sufentanil 10µg in 2ml of normal saline on induction of anesthesia + per-operative injection of sufentanil 5µg in 1ml of normal saline during the surgery if needed.
Pre-operative infusion of dexmedetomidine 1µg/kg in 100ml of normal saline before surgery + per-operative infusion of dexmedetomidine 0.4 µg/kg in 100ml of normal saline during the surgery if needed.
Clinique Médipôle Garonne
Toulouse, Haute-Garonne, France
Postoperative analgesia, defined by the oxycodone consumption in the first 24 hours post-surgery
Postoperative cumulated dose of oxycodone in oral morphine equivalent (mg)
Time frame: 24 hours
Analgesia in post-anesthesia care unit (PACU)
Total amount of oxycodone (mg) administered in PACU
Time frame: 6 hours
Postoperative pain at rest
Postoperative pain at rest (numeric rating scale ranging from 0 to 10: 0= no pain; 10= worst imaginable pain)
Time frame: 24 hours
Postoperative pain at walk
Postoperative pain at mobilization (numeric rating scale ranging from 0 to 10: 0= no pain; 10= worst imaginable pain)
Time frame: 24 hours
Side effects associated with opioids
Complications due to oxycodone (postoperative nausea and vomiting, drowsiness, acute urinary retention, pruritus, disorientation)
Time frame: 24 hours
Side effects associated with dexmedetomidine
Complications due to dexmedetomidine (bradycardia defined by HR\<50 bpm or requiring the use of atropine; hypotension defined by SBP\<90 mmHg or requiring the use of vasoconstrictors; hypertension defined by SBP\>160 mmHg).
Time frame: 24 hours
Outpatient care failure
Unplanned hospitalizations
Time frame: 24 hours
Length of stay in post-anesthesia care unit (PACU)
Duration of PACU stay (min)
Time frame: 6 hours
Time to recover the ability to walk
Duration for recovery the ability to walk (min)
Time frame: 12 hours
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