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

C

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)

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

Trial contacts and locations

1

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Central trial contact

Pierre HUETTE, DR

Data sourced from clinicaltrials.gov

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