Total Hip Arthroplasty (THA)NCT07747142
Comparison Between Opioid-sparing Anesthesia Guided by the CARDEAN® Index and Opioid-free Anesthesia During Total Hip Arthroplasty
A study testing Titrated Opioid Sparing Anesthesia and opioid free anesthesia in people with Total Hip Arthroplasty (THA), run by Pole Sante Oreliance, Polyclinique des Longues Allees at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Arthroplasty (THA)
- What is being tested?
- Titrated Opioid Sparing Anesthesia and opioid free anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2026to 1 Oct 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Pole Sante Oreliance, Polyclinique des Longues Allees
Saran, 45770
Jean-Yves Martinez, Doctor, +33 2 38 79 61 85, jyvesmartinez@yahoo.com
About this study
Official title: Comparaison Entre anesthésie Avec épargne Morphinique guidée Par l'Index CARDEAN® et anesthésie Sans Morphinique au Cours Des Arthroplasties Totales de Hanche : étude randomisée
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).
- Conditions
- Total Hip Arthroplasty (THA)
- Being tested
- Titrated Opioid Sparing Anesthesia, opioid free anesthesia
- Keywords
- Cardean, OSA, OFA, anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titrated Opioid Sparing AnesthesiaProcedure or surgery
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).
opioid free anesthesiaProcedure or surgery
anesthesia performed without opioid administration
| Study group | Role | What they receive |
|---|---|---|
| Titrated Opioid Sparing Anesthesia | Experimental | Not described Receives: Procedure: Titrated Opioid Sparing Anesthesia |
| Opioid Free Anesthesia | Active comparator | Not described Receives: Procedure: opioid free anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: During the first 24 hours after the start of anesthesia
Secondary outcomes (13)
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
Measured: During intervention
Speed of emergence from anesthesia in the post-anesthesia care unit (PACU)
Measured: 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
Measured: 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)
Measured: 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).
Measured: Until 24 hours after surgery
Patient satisfaction: satisfaction questionnaire (completed on the day of discharge) regarding the management of any pain.
Measured: 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
Measured: On postoperative days 1 and 2
IV morphine dose received in the PACU, expressed in MME
Measured: 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)
Measured: Every 6 hours until 48 hours after surgery
Number of patients not receiving morphine in the PACU
Measured: during the awakening, 24 hours after surgery, 48 hours after surgery
Presence of postoperative nausea and/or vomiting (PONV)
Measured: Until up to 48 hours after surgery
Acute urinary retention (defined by the presence of a bladder volume > 600 ml requiring urinary catheterization)
Measured: 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)
Measured: After surgery just before discharge (between 24 and 48 hours after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start15 Sep 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Total Hip Arthroplasty (THA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pole Sante Oreliance, Polyclinique des Longues Allees
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747142
- Sponsor's protocol ID
- ID-RCB-2026-A00810-51
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pedersen C, Vilhelmsen FJ, Laigaard J, Mathiesen O, Karlsen APH. Opioid consumption and non-opioid multimodal analgesic treatment in pain management trials after hip and knee arthroplasties: A meta-epidemiological study. Acta Anaesthesiol Scand. 2023 May;67(5):613-620. doi: 10.1111/aas.14213. Epub 2023 Feb 21.
PubMed 36759566Laigaard J, Pedersen C, Ronsbo TN, Mathiesen O, Karlsen APH. Minimal clinically important differences in randomised clinical trials on pain management after total hip and knee arthroplasty: a systematic review. Br J Anaesth. 2021 May;126(5):1029-1037. doi: 10.1016/j.bja.2021.01.021. Epub 2021 Mar 5.
PubMed 33678402Wey PF, Loheas D, Lamblin A, Riche B, Rabilloud M, Escarment J, Puidupin M, Quintin L, Martinez JY, Cividjian A. A beat-by-beat cardiovascular index, CARDEAN, to titrate opioid administration in the setting of orthopaedic surgery: a prospective randomized trial. J Clin Monit Comput. 2021 Dec;35(6):1311-1324. doi: 10.1007/s10877-020-00597-6. Epub 2020 Oct 6.
PubMed 33025323Papaioannou V, Chouvarda I, Gaertner E, Benyamina M, Ferry A, Maurel V, Soussi S, Blet A, Chaouat M, Plaud B, Mebazaa A, Legrand M; PRONOBURN Group. Heart rate variability and cardiac baroreflex inhibition-derived index predicts pain perception in burn patients. Burns. 2016 Nov;42(7):1445-1454. doi: 10.1016/j.burns.2016.04.017. Epub 2016 May 8.
PubMed 27170468Rossi M, Cividjian A, Fevre MC, Oddoux ME, Carcey J, Halle C, Frost M, Gardellin M, Payen JF, Quintin L. A beat-by-beat, on-line, cardiovascular index, CARDEAN, to assess circulatory responses to surgery: a randomized clinical trial during spine surgery. J Clin Monit Comput. 2012 Dec;26(6):441-9. doi: 10.1007/s10877-012-9372-y. Epub 2012 Jun 10.
PubMed 22684738Martinez JY, Wey PF, Lions C, Cividjian A, Rabilloud M, Bissery A, Bourdon L, Puidupin M, Escarment J, Quintin L. A beat-by-beat cardiovascular index, CARDEAN: a prospective randomized assessment of its utility for the reduction of movement during colonoscopy. Anesth Analg. 2010 Mar 1;110(3):765-72. doi: 10.1213/ANE.0b013e3181cc9ebe.
PubMed 20185655Cividjian A, Martinez JY, Combourieu E, Precloux P, Beraud AM, Rochette Y, Cler M, Bourdon L, Escarment J, Quintin L. Beat-by-beat cardiovascular index to predict unexpected intraoperative movement in anesthetized unparalyzed patients: a retrospective analysis. J Clin Monit Comput. 2007 Apr;21(2):91-101. doi: 10.1007/s10877-006-9061-9. Epub 2006 Dec 22.
PubMed 17186401Ao Y, Ma J, Zheng X, Zeng J, Wei K. Opioid-Sparing Anesthesia Versus Opioid-Free Anesthesia for the Prevention of Postoperative Nausea and Vomiting after Laparoscopic Bariatric Surgery: A Systematic Review and Network Meta-Analysis. Anesth Analg. 2025 Feb 1;140(2):385-396. doi: 10.1213/ANE.0000000000006942. Epub 2024 Apr 5.
PubMed 38578868Collange V, Berruet JB, Aubrun F, Poiblanc M, Olagne E, Golliet Mercier N, Parent S, Noel P, Devillez S, Perrou M, Ramadan J, Coeckelenbergh S, Joosten A. Opioid free versus opioid sparing strategies for multimodal antinociception during laparoscopic colectomy: a randomised controlled trial. Anaesth Crit Care Pain Med. 2024 Dec;43(6):101436. doi: 10.1016/j.accpm.2024.101436. Epub 2024 Oct 9.
PubMed 39393528Salome A, Harkouk H, Fletcher D, Martinez V. Opioid-Free Anesthesia Benefit-Risk Balance: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2021 May 12;10(10):2069. doi: 10.3390/jcm10102069.
PubMed 34065937Urvoy B, Aveline C, Belot N, Catier C, Beloeil H. Opioid-free anaesthesia for anterior total hip replacement under general anaesthesia: the Observational Prospective Study of Opiate-free Anesthesia for Anterior Total Hip Replacement trial. Br J Anaesth. 2021 Apr;126(4):e136-e139. doi: 10.1016/j.bja.2021.01.001. Epub 2021 Feb 3. No abstract available.
PubMed 33549323Beloeil H, Garot M, Lebuffe G, Gerbaud A, Bila J, Cuvillon P, Dubout E, Oger S, Nadaud J, Becret A, Coullier N, Lecoeur S, Fayon J, Godet T, Mazerolles M, Atallah F, Sigaut S, Choinier PM, Asehnoune K, Roquilly A, Chanques G, Esvan M, Futier E, Laviolle B; POFA Study Group; SFAR Research Network. Balanced Opioid-free Anesthesia with Dexmedetomidine versus Balanced Anesthesia with Remifentanil for Major or Intermediate Noncardiac Surgery. Anesthesiology. 2021 Apr 1;134(4):541-551. doi: 10.1097/ALN.0000000000003725.
PubMed 33630043Chassery C, Atthar V, Marty P, Vuillaume C, Casalprim J, Basset B, De Lussy A, Naudin C, Joshi GP, Rontes O. Opioid-free versus opioid-sparing anaesthesia in ambulatory total hip arthroplasty: a randomised controlled trial. Br J Anaesth. 2024 Feb;132(2):352-358. doi: 10.1016/j.bja.2023.10.031. Epub 2023 Dec 2.
PubMed 38044236Albrecht E, Grape S, Frauenknecht J, Kilchoer L, Kirkham KR. Low- versus high-dose intraoperative opioids: A systematic review with meta-analyses and trial sequential analyses. Acta Anaesthesiol Scand. 2020 Jan;64(1):6-22. doi: 10.1111/aas.13470. Epub 2019 Oct 7.
PubMed 31506922Colvin LA, Bull F, Hales TG. Perioperative opioid analgesia-when is enough too much? A review of opioid-induced tolerance and hyperalgesia. Lancet. 2019 Apr 13;393(10180):1558-1568. doi: 10.1016/S0140-6736(19)30430-1.
PubMed 30983591