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

Centre Hospitalier Universitaire, Amiens

Status and phase: Enrolling; Phase 3

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

Treatments: Drug: parasternal block; Drug: Standard pain management

Study type: Interventional

Funder types: Other

Identifiers

NCT05515809

PI2021_843_0229

Details and patient eligibility

About

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

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

interventional arm

Experimental group

Description:

the experimental arm will receive the parasternal block with injection of locoregional anesthesia

Treatment:

Drug: parasternal block

control arm not requiring loco-regional anesthesia.

Active Comparator group

Description:

the control arm will receive a standard treatment, without locoregional anesthesia

Treatment:

Drug: Standard pain management