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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05515809
Acronym
PARACARD
Enrollment
84
Registered
2022-08-25
Start date
2022-07-19
Completion date
2025-06-30
Last updated
2025-05-28

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

Conditions

Cardiac Surgery, Postoperative Pulmonary Complications, Pulmonary Function Testing, Ultrasound-guided Parasternal Block

Keywords

Cardiac surgery, Ultrasound-guided Parasternal Block, Postoperative pulmonary complications, Pulmonary function testing

Brief 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

Interventions

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

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Change in postoperative forced vital capacity (FVC)1 dayThe 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.

Secondary

MeasureTime frameDescription
Variation of forced expiratory volume in 1 second (FEV1)at day 2Respiratory functional investigations at day 2 are forced expiratory volume in 1 second (FEV1)
Variation of FCV between both groupsat day 2Respiratory functional investigations at day 2 is forced vital capacity (FVC)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026