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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:
If needed after incision :
OFA group (experimental group):
If needed after incision :
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Sufentanil IV injection |
|
| OFA group | Experimental | Dexmedetomidine IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sufentanil | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative analgesia, defined by the oxycodone consumption in the first 24 hours post-surgery | Postoperative cumulated dose of oxycodone in oral morphine equivalent (mg) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesia in post-anesthesia care unit (PACU) | Total amount of oxycodone (mg) administered in PACU | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Médipôle Garonne | Toulouse | Haute-Garonne | 31036 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38044236 | Result | Chassery C, Atthar V, Marty P, Vuillaume C, Casalprim J, Basset B, De Lussy A, Naudin C, Joshi GP, Rontes O. Opioid-free versus opioid-sparing anaesthesia in ambulatory total hip arthroplasty: a randomised controlled trial. Br J Anaesth. 2024 Feb;132(2):352-358. doi: 10.1016/j.bja.2023.10.031. Epub 2023 Dec 2. |
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| ID | Term |
|---|---|
| D017409 | Sufentanil |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Dexmedetomidine | Drug | 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. |
|
| 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) | 24 hours |
| Side effects associated with opioids | Complications due to oxycodone (postoperative nausea and vomiting, drowsiness, acute urinary retention, pruritus, disorientation) | 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). | 24 hours |
| Outpatient care failure | Unplanned hospitalizations | 24 hours |
| Length of stay in post-anesthesia care unit (PACU) | Duration of PACU stay (min) | 6 hours |
| Time to recover the ability to walk | Duration for recovery the ability to walk (min) | 12 hours |
| D007093 |
| Imidazoles |
| D001393 | Azoles |