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Evaluation of the Effectiveness of Ultrasound-Guided Stellate Ganglion Block in Cardiac Surgery Anesthesia on Postoperative Recovery

Evaluation of the Effectiveness of Ultrasound-Guided Stellate Ganglion Block in Cardiac Surgery Anesthesia on Postoperative Recovery: A Multicenter, Randomized, Double-Blind Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07676487
Acronym
ECLAIR
Enrollment
250
Registered
2026-06-30
Start date
2026-07-01
Completion date
2028-02-01
Last updated
2026-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiopulmonary Bypass, CPB, Undergo Elective Cardiac Surgery

Brief summary

Heart surgery is a complex and delicate procedure that affects more than one million people worldwide each year. Patients who undergo this surgery are generally elderly and have multiple comorbidities, which places them in high-risk categories (ASA III or IV). This frailty, combined with a loss of physiological reserve, makes these patients particularly vulnerable to postoperative complications, which can range from cardiovascular disorders to neurological, respiratory, renal, gastrointestinal, infectious, and hematological complications. In this context, the quality of postoperative recovery is crucial because it reflects the patient's postoperative health status. The quality of recovery encompasses several dimensions, such as pain, return to independence, sleep quality, and mental state. Optimal anesthesia-which goes beyond simply minimizing pain-requires proactive management of all these dimensions. Current research in cardiac surgery focuses on optimizing anesthesia strategies, particularly the choice between opioid and non-opioid anesthesia, as well as the complementary use of regional analgesia. However, studies providing clear recommendations on these topics are still limited. Among the techniques explored, the ultrasound-guided stellate ganglion block (SGB) stands out due to its numerous positive clinical effects. This block, which involves the ultrasound-guided injection of a local anesthetic into the stellate ganglion, produces a temporary sympathetic block that reduces the activity of the autonomic nervous system during surgery. Several studies suggest that SGB could significantly improve the quality of postoperative recovery, particularly in terms of pain reduction, sleep quality, and a lower incidence of cardiac arrhythmias. A meta-analysis has shown that SGB promotes the recovery of gastrointestinal function following various surgical procedures. In major thoracic surgery, it has been observed that SGB reduces the incidence of perioperative atrial and ventricular fibrillation. Although these results are promising, data from randomized trials in cardiac surgery are still limited. A pilot study demonstrated the feasibility and safety of SGB in this type of surgery, with a reduced incidence of atrial fibrillation. However, further studies are essential to confirm these results and assess the impact of SGB on the quality of recovery following anesthesia in cardiac surgery. The hypothesis of this study is that performing a stellate ganglion block during general anesthesia improves the quality of recovery in all its aspects (pain, well-being, sleep, etc.). This hypothesis warrants in-depth exploration to optimize postoperative care and improve long-term outcomes for patients undergoing complex cardiac surgery.

Interventions

PROCEDUREElective surgery (≥ 24 hours) with cardiopulmonary bypass (more than 2 procedures)

Patient scheduled to undergo surgery (≥ 24 hours) involving cardiopulmonary bypass (CPB) for more than two procedures

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Individuals who have provided their free and informed written consent * Age ≥18 years * Patients scheduled to undergo elective cardiac surgery (≥24 hours) with cardiopulmonary bypass (CPB): valve surgery, aorto-coronary bypass surgery, or combined surgery (\>2 procedures)

Exclusion criteria

* Adult under guardianship * Patient not enrolled in a social security program * Patient who has previously been included in the study (e.g., repeat surgery) * Patient with hypersensitivity to local anesthetics or to any of the excipients in the products used * Preoperative AC/FA * Hypovolemia * Severe hypotension * Acute porphyria * Pregnant, laboring, or breastfeeding women

Design outcomes

Primary

MeasureTime frameDescription
Score obtained on the validated psychometric scale F-QoR-15 (French Quality of Recovery-15 questionnaire) at 24 hours post-surgery in the intervention group (general anesthesia + ultrasound-guided nerve block), compared with the control group (general an24 hours after surgeryThe French Quality of Recovery-15 questionnaire is a self-reported measure of overall postoperative recovery. The tool contains 15 questions covering 4 dimensions: physical comfort (5 items), emotional state (4 items), pain (2 items), physical autonomy (2 items), and psychological support (2 items). Each item is rated on a scale of 0 to 10, and the overall score is the sum of the scores obtained for each item, allowing for the classification of recovery quality: 0-89 ("extremely poor QoR"), 90-121 (moderate QoR), 122-135 ("good QoR"), and 136-150 ("excellent QoR").

Countries

France

Contacts

CONTACTPierre-Alain BAHR
pierre-alain.bahr@chu-dijon.fr03.80.29.30.79

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 24, 2026