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NCT Number: NCT05515809

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Amiens-Picardie

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

parasternal block

Drug

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

Drug

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

Primary outcomes

  1. Change in postoperative forced vital capacity (FVC)

    Time frame: 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.

Secondary outcomes

  1. Variation of FCV between both groups

    Time frame: at day 2

    Respiratory functional investigations at day 2 is forced vital capacity (FVC)

  2. Variation of FCV between both groups

    Time frame: at 1 month

    Respiratory functional investigations at 1 month is forced vital capacity (FVC)

  3. Variation of FCV between both groups

    Time frame: at 3 months

    Respiratory functional investigations at 3 months is forced vital capacity (FVC)

  4. Variation of forced expiratory volume in 1 second (FEV1)

    Time frame: at day 2

    Respiratory functional investigations at day 2 are forced expiratory volume in 1 second (FEV1)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: PARACARD

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 25, 2022
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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