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Clinical Trials in France / NCT05515809
Active, not recruiting Phase 3

Evaluation of the Effect of Para-sternal Block on Postoperative Respiratory Function After Cardiac Sternotomy Surgery

NCT05515809 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Universitaire, Amiens
Phase
Phase 3
Started
2022-07-19
Last updated
2025-05-28

Condition(s) studied

Cardiac SurgeryUltrasound-guided Parasternal BlockPostoperative Pulmonary ComplicationsPulmonary Function Testing

Investigational drug(s) / intervention(s)

parasternal blockStandard pain management

parasternal block: Echo-guided loco-regional anesthesia by bilateral parasternal block in immediate preoperative. The drug used is Ropivacaine 2mg/ml, 0.2%. Injection of 20ml per side, under ultrasound control, after general anaesthesia and before skin incision, and therefore before surgery

Standard pain management: Standard pain management care involves a multimodal strategy that includes the use of intravenous analgesics. Morphine medications are the mainstay of pain management

Study summary

Postoperative pain after cardiac surgery is associated with reduced postoperative respiratory function. There is an association between greater pain and more pronounced decreases in lung volumes postoperatively. With an incidence of 10% to 25% of cases, pulmonary complications are the second source of postoperative morbidity after cardiac complications; in 2-5% of cases, the dysfunction is severe and leads to significant consequences that can lead to death. It has been shown that postoperative pain after cardiac surgery is associated with a reduction in functional respiratory capacity. There is an association between greater pain and more pronounced decreases in lung volumes postoperatively. The main objective of this study will be to evaluate the impact of locoregional anesthesia by parasternal block analgesic on postoperative respiratory function at D1 postoperatively

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients over 18 years of age * Elective cardiac surgery under CEC with sternotomy * Written informed consent from the patient. * Women of childbearing age must have a negative urine HCG pregnancy test. Exclusion Criteria: * Thoracotomy approach * Mini-sternotomy approach * Opioid drug dependence or chronic opioid drug use * Chronic benzodiazepine use (respiratory depressant treatment or treatment that may affect postoperative respiratory function) * Contraindication or allergy to local anesthetics * Emergency surgery * Acute infective endocarditis * Immunosuppressive or steroid treatment (prednisone \> 0.5mg/kg/day or equivalent) * AIDS with CD4 count \<200/mm3 * Autoimmune disorder * Transplant recipient * Inclusion in another study within the last 30 days. * Pregnancy

Primary outcome measure(s)

  • Change in postoperative forced vital capacity (FVC) — 1 day
    The primary endpoint was the change (reduction) in postoperative forced vital capacity (FVC) between the preoperative measurement and at D1 postoperatively. * "Forced Vital Capacity measured by SPIROLAB spirometry (Appendix). * "Vital capacity is expressed as % of theoretical value.

Trial sites (1)

FacilityCityRegionStatus
CHU Amiens-Picardie Amiens France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05515809 on ClinicalTrials.gov ↗ ← All trials in France