Total Hip Arthroplasty (THA)
Conditions
Keywords
Cardean, OSA, OFA, anesthesia
Brief summary
The proposed study compares two anesthesia techniques; the hypothesis being tested is that titrating sufentanil based on the CARDEAN® index (titrated OSA) does not increase post-operative morphine consumption compared to opioid-free anesthesia (OFA). This CARDEAN®-guided titrated anesthesia approach could potentially allow for hospital discharge as early as 24 hours post-operatively and is compatible with ERAS protocols. The primary objective is to demonstrate that sufentanil administration guided by the CARDEAN® index (titrated OSA) does not increase postoperative morphine consumption compared to opioid-free anesthesia (OFA). This is a prospective, single-center, randomized, single-blind, non-inferiority study. Two groups of 70 patients each (140 patients in total) are compared based on the type of intraoperative analgesia: titrated OSA (Arm 1) versus OFA (Arm 2). Randomization will be performed at a 1:1 ratio and stratified by surgical approach (anterior or lateral approach).
Interventions
PROCEDURETitrated Opioid Sparing Anesthesia
Opioid-sparing anesthesia using the CARDEAN® index, which enables specific monitoring of nociception during general anesthesia. By adjusting sufentanil administration in real time based on variations in surgical painful stimuli, the CARDEAN® index enables titrated opioid-sparing anesthesia (titrated OSA).
PROCEDUREopioid free anesthesia
anesthesia performed without opioid administration
Sponsors
Pole Sante Oreliance, Polyclinique des Longues Allees
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women * Patient aged at least 18 years * Signed informed consent * American Society of Anesthesiologists (ASA) Class 1 to 3 * Scheduled total hip arthroplasty under general anesthesia (anterior or lateral approach) with local analgesic infiltration performed by the surgeon at the end of the procedure * Affiliated with or a beneficiary of a social security scheme.
Exclusion criteria
* ASA Class 4 or 5 * Emergency hip surgery * Indication for an anesthesia technique other than general anesthesia (patient preference, benefit-risk ratio, etc.) * Permanent cardiac arrhythmia or permanent cardiac pacing (invalid CARDEAN® index) * Resting bradycardia \< 50 bpm * Second- or third-degree atrioventricular block * Chronic opioid user * Refusal of consent * Patient unable to read, write, or understand French * Vulnerable patient as defined by Article L1121-6 of the Public Health Code (CSP) * Adult patient under guardianship, curatorship, or judicial protection * Patient unable to personally provide consent as defined by Article L.1121-8 of the CSP, or an adult under legal protection * Pregnant or breastfeeding woman as defined by Article L1121-5 of the CSP
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total dose of morphine required to maintain a pain score ≤ 3 on a numerical scale of 1 to 10 during the first 24 hours (dose expressed as oral morphine equivalent, OME) | During the first 24 hours after the start of anesthesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stability of heart rate (HR) and mean arterial pressure (MAP) | During intervention | * Number of heart rate episodes deviating by ±20% for more than 15 seconds from the baseline heart rate, relative to the duration of the procedure * Number of mean arterial pressure (MAP) values deviating by ±20% from the baseline MAP, relative to the duration of the procedure * Number of boluses and total doses of cardiotropic and vasoactive drugs: atropine, norepinephrine, nicardipine |
| Speed of emergence from anesthesia in the post-anesthesia care unit (PACU) | Time interval between the end of the procedure and extubation | — |
| Postoperative pain control | During awakening, at day 1 and day 2 after surgery | Maximum pain score on a 0-10 numerical rating scale (NRS max) in the PACU |
| Adverse effects of postoperative opioids | During the awakening | Number of hypoxia episodes in the PACU (hypoxia defined as SpO2 ≤ 94% on room air) |
| Discharge from the hospital is possible as early as 24 hours post-procedure for patients deemed eligible for early discharge (determined by the surgeon prior to the intervention). | Until 24 hours after surgery | — |
| Patient satisfaction: satisfaction questionnaire (completed on the day of discharge) regarding the management of any pain. | At discharge (between 24 and 48 hours after surgery) | — |
| Maximum pain score on a 0-10 numerical rating scale (NRS max) at rest and during movement | On postoperative days 1 and 2 | — |
| IV morphine dose received in the PACU, expressed in MME | during the awakening | — |
| Morphine dose received in the surgical ward, expressed in MME, at 6, 12, 18, 24, 36, and 48 hours post-surgery (H0 = start of surgery) | Every 6 hours until 48 hours after surgery | — |
| Number of patients not receiving morphine in the PACU | during the awakening, 24 hours after surgery, 48 hours after surgery | — |
| Presence of postoperative nausea and/or vomiting (PONV) | Until up to 48 hours after surgery | — |
| Acute urinary retention (defined by the presence of a bladder volume > 600 ml requiring urinary catheterization) | Until up to 48 hours after surgery | — |
| Postoperative confusional state: preoperative cognitive test (Mini-Cog) and screening for postoperative confusional state (Confusion Assessment Method, CAM) | After surgery just before discharge (between 24 and 48 hours after surgery) | — |
Countries
France
Contacts
CONTACTJean-Yves JY Martinez, Doctor
Outcome results
None listed