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

Cardiac Surgery Clinical Trial

— PARACARD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05515809
• Other study ID #: PI2021_843_0229
• Status: Recruiting
• Phase: Phase 3
• Start date: July 19, 2022
• Est. completion date: October 2023

Study information

• Verified date: July 2022
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Pierre HUETTE, DR
• Phone: 03 22 08 78 99
• Email: huette.pierre[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: October 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery
• Postoperative Pulmonary Complications
• Pulmonary Function Testing

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens-Picardie	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in postoperative forced vital capacity (FVC)	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.	1 day
Secondary	Variation of FCV between both groups	Respiratory functional investigations at day 2 is forced vital capacity (FVC)	at day 2
Secondary	Variation of FCV between both groups	Respiratory functional investigations at 1 month is forced vital capacity (FVC)	at 1 month
Secondary	Variation of FCV between both groups	Respiratory functional investigations at 3 months is forced vital capacity (FVC)	at 3 months
Secondary	Variation of forced expiratory volume in 1 second (FEV1)	Respiratory functional investigations at day 2 are forced expiratory volume in 1 second (FEV1)	at day 2