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Not yet recruitingNCT07676487ECLAIRUpdated Jul 23, 2026

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

An interventional study of Elective surgery (≥ 24 hours) with cardiopulmonary bypass (more than 2 procedures) in Undergo Elective Cardiac Surgery, Cardiopulmonary Bypass and CPB, sponsored by Centre Hospitalier Universitaire Dijon. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.

Sponsored by Centre Hospitalier Universitaire Dijon · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Undergo Elective Cardiac Surgery
  • Cardiopulmonary Bypass
  • CPB
03

In context

Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 495 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
250 participants (estimated)

Study arms

  • Experimental
    Ultrasound-Guided Stellate Ganglion Block (SGB) Group under general anesthesia

    Procedure: Elective surgery (≥ 24 hours) with cardiopulmonary bypass (more than 2 procedures)

  • Other
    Control group under general anesthesia

    Procedure: Elective surgery (≥ 24 hours) with cardiopulmonary bypass (more than 2 procedures)

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

06

What researchers measure

Primary outcomes

  1. 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 an

    The 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").

    Time frame: 24 hours after surgery

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07676487
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
Jun 30, 2026
Start date
Jul 2026 (estimated)
Primary completion
Feb 2028 (estimated)
Completion
Feb 2028 (estimated)
Last update
Jul 23, 2026

Study contacts

Pierre-Alain BAHR
Contact
pierre-alain.bahr@chu-dijon.fr
03.80.29.30.79 ext. +33

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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