Opioid Free Anesthesia in Total Hip Arthroplasty (OFATHA)
-
- STATUS
- Recruiting
-
- End date
- Aug 4, 2023
-
- participants needed
- 80
-
- sponsor
- CMC Ambroise Paré
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.
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.
Details
| Condition | Primary Total Hip Arthroplasty |
|---|---|
| Treatment | Dexmedetomidine, Sufentanil |
| Clinical Study Identifier | NCT05072704 |
| Sponsor | CMC Ambroise Paré |
| Last Modified on | 26 March 2022 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer