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

Phase 3Active Not RecruitingNCT05515809

Centre Hospitalier Universitaire, Amiens84 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cardiac Surgery Ultrasound-guided Parasternal Block Postoperative Pulmonary Complications

Interventions

parasternal blockDRUG

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 managementDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 1 day

Secondary Outcomes

Variation of FCV between both groups

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

Time frame: at day 2

Variation of FCV between both groups

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

Time frame: at 1 month

Variation of FCV between both groups

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

Time frame: at 3 months

Variation of forced expiratory volume in 1 second (FEV1)

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

Time frame: at day 2

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes