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

Phase 3

• Conditions: Pulmonary Function Testing; Cardiac Surgery; Ultrasound-guided Parasternal Block; Postoperative Pulmonary Complications
• Interventions: Drug: parasternal block; Drug: Standard pain management

• Registration Number: NCT05515809
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-07
• Study Start: 2022-07-19
• Study First Submitted: 2022-07-28
• Study First Submitted QC: 2022-08-23
• Study First Posted: 2022-08-25
• Last Update Submitted: 2022-09-06
• Last Update Posted: 2022-09-07
• Primary Completion: 2023-07
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
interventional arm	parasternal block	the experimental arm will receive the parasternal block with injection of locoregional anesthesia
control arm not requiring loco-regional anesthesia.	Standard pain management	the control arm will receive a standard treatment, without locoregional anesthesia

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Variation of FCV between both groups	at 3 months	Respiratory functional investigations at 3 months is forced vital capacity (FVC)
Variation of forced expiratory volume in 1 second (FEV1)	at day 2	Respiratory functional investigations at day 2 are forced expiratory volume in 1 second (FEV1)

Trial Locations

Locations (1)

CHU Amiens-Picardie; 🇫🇷 Amiens, France