Comparison Between Opioid-sparing Anesthesia Guided by the CARDEAN® Index and Opioid-free Anesthesia During Total Hip Arthroplasty

N/ANot Yet RecruitingNCT07747142

Pole Sante Oreliance, Polyclinique des Longues Allees140 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

140

Conditions

Total Hip Arthroplasty (THA)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: During the first 24 hours after the start of anesthesia

Secondary Outcomes

Stability of heart rate (HR) and mean arterial pressure (MAP)

* 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

Time frame: During intervention

Speed of emergence from anesthesia in the post-anesthesia care unit (PACU)

Time frame: Time interval between the end of the procedure and extubation

Postoperative pain control

Maximum pain score on a 0-10 numerical rating scale (NRS max) in the PACU

Time frame: During awakening, at day 1 and day 2 after surgery

Adverse effects of postoperative opioids

Number of hypoxia episodes in the PACU (hypoxia defined as SpO2 ≤ 94% on room air)

Time frame: During the awakening

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).

Time frame: Until 24 hours after surgery

Patient satisfaction: satisfaction questionnaire (completed on the day of discharge) regarding the management of any pain.

Time frame: 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

Time frame: On postoperative days 1 and 2

IV morphine dose received in the PACU, expressed in MME

Time frame: 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)

Time frame: Every 6 hours until 48 hours after surgery

Number of patients not receiving morphine in the PACU

Time frame: during the awakening, 24 hours after surgery, 48 hours after surgery

Presence of postoperative nausea and/or vomiting (PONV)

Time frame: Until up to 48 hours after surgery

Acute urinary retention (defined by the presence of a bladder volume > 600 ml requiring urinary catheterization)

Time frame: 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)

Time frame: After surgery just before discharge (between 24 and 48 hours after surgery)