Evaluation of the Effect of Para-sternal Block on Postoperative Respiratory Function After Cardiac Sternotomy Surgery
概览
- 阶段
- 3 期
- 干预措施
- parasternal block
- 疾病 / 适应症
- Cardiac Surgery
- 发起方
- Centre Hospitalier Universitaire, Amiens
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in postoperative forced vital capacity (FVC)
- 状态
- 进行中（未招募）
- 最后更新
- 11个月前
概览
简要总结
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
研究者
入排标准
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
interventional arm
the experimental arm will receive the parasternal block with injection of locoregional anesthesia
干预措施: parasternal block
control arm not requiring loco-regional anesthesia.
the control arm will receive a standard treatment, without locoregional anesthesia
干预措施: Standard pain management
结局指标
主要结局
Change in postoperative forced vital capacity (FVC)
时间窗: 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.
次要结局
- Variation of FCV between both groups(at 3 months)
- Variation of forced expiratory volume in 1 second (FEV1)(at day 2)