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

NCT07676487 | Not Yet Recruiting

• 1 other identifier: BAHR PHRCI 2024
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Undergo Elective Cardiac Surgery; Cardiopulmonary Bypass; CPB

Outcome Measures

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").

  24 hours after surgery

Study Arms (2)

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

EXPERIMENTAL

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

Control group under general anesthesia

OTHER

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

Interventions

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

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

Control group under general anesthesia; Ultrasound-Guided Stellate Ganglion Block (SGB) Group under general anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, France

Location

MeSH Terms

Interventions

Elective Surgical Procedures; Cardiopulmonary Bypass

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Extracorporeal Circulation

Central Study Contacts

Pierre-Alain BAHR

CONTACT

03.80.29.30.79; pierre-alain.bahr@chu-dijon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

FR (1)