Clinique Médipôle Garonne
Toulouse, Haute-Garonne, 31036, France
NCT Number: NCT05072704
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 3
Toulouse, Haute-Garonne, 31036, France
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 :
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 24 hours
Postoperative cumulated dose of oxycodone in oral morphine equivalent (mg)
Time frame: 6 hours
Total amount of oxycodone (mg) administered in PACU
Time frame: 24 hours
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 mobilization (numeric rating scale ranging from 0 to 10: 0= no pain; 10= worst imaginable pain)
Time frame: 24 hours
Complications due to oxycodone (postoperative nausea and vomiting, drowsiness, acute urinary retention, pruritus, disorientation)
Time frame: 24 hours
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
Unplanned hospitalizations
Time frame: 6 hours
Duration of PACU stay (min)
Time frame: 12 hours
Duration for recovery the ability to walk (min)
CMC Ambroise Paré
Other
Opioid Free Anesthesia in Total Hip Arthroplasty. A Randomized, Controlled and Triple-blind Clinical Trial
Acronym: OFATHA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04122157
Primary Total Hip Arthroplasty
View Trial DetailsNCT04209426
Primary Total Hip Arthroplasty, Revision Total Hip Arthroplasty
Challes-les-Eaux, France
View Trial DetailsNCT03973320
Cardiovascular Diseases, Database
New York, United States
View Trial DetailsNCT03968939
Primary Total Hip Arthroplasty, Primary Total Knee Arthroplasty
Columbia, Missouri, United States
View Trial Details