Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-27 @ 6:06 AM
Study NCT ID:
NCT05072704
Status:
COMPLETED
Last Update Posted:
2023-02-22
First Post:
2021-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Opioid Free Anesthesia in Total Hip Arthroplasty
Sponsor:
CMC Ambroise Paré
Organization:
Study Overview
Official Title:
Opioid Free Anesthesia in Total Hip Arthroplasty. A Randomized, Controlled and Triple-blind Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OFATHA
Brief 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.
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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: