Erector Spinae Plane Block Versus Paravertebral Block for Analgesic Outcomes After Cardiac Surgery (PEPS): a Prospective Randomized Comparative Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Pain assessment
研究概览
简要总结
The purpose of this randomized double-blind study is to compare the analgesic efficacy of the bilateral Erector Spinae Plane (ESP) block versus the bilateral Thoracic Paravertebral block (TPVB), by ultrasound-guided single injection in patients who underwent sternotomy for cardiac surgery.
详细描述
Cardiac surgery causes moderate to severe postoperative pain during the first 24 - 48 post-operative hours. This pain is greatly increased by mobilization (respiratory physiotherapy) and leads to the consumption of morphine.
Appropriate analgesia, along with a reduction in morphine consumption are important factors in reducing morbidity after cardiac surgery and allow better postoperative rehabilitation.
Recently, the concept of multimodal analgesia has become established, which corresponds to ensuring optimal analgesia through the use of non-morphine drugs associated with locoregional analgesia.
During cardiac surgery, Paravertebral block (TPVB) technique is the first line of reference in our establishment. Lately, a new approach of blocking the intercostal nerves called Erector Spinae Plane block (ESP) has been discovered. It is a technique that seems simpler and safer than TPVB.
Until now, the analgesic efficacy of the ESP block compared to TPVB after cardiac surgery by sternotomy has never been studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing any (scheduled) surgery of the heart (valve or coronary surgery) via a median sternotomy
- •Physical status classification (ASA) ≤3
- •Patients benefiting from a Social Security scheme or benefiting from it through a third party
排除标准
- •Emergency cardiac surgery
- •Exclusion criteria related to cardiac surgery with thoracotomy, occurrence of aortic dissection, redo surgery.
- •Aortic counterpulsation
- •Preoperative cardiogenic shock
- •LVEF< 30%
- •Severe preoperative chronic or acute renal failure with creatinine clearance less than 30 mL / min according to the MDRD formula
- •Pre-existing psychiatric pathology, including addiction to opioids
- •Physical or intellectual incapacity to use a PCA
- •Known allergy or hypersensitivity to any of the study drugs or analgesia protocol (ropivacaine, paracetamol, opioids)
- •Contraindication for performing the paravertebral block and Erector of the spine (ESP): Infection at the site of injection, severe hemostasis disorder, thoracic spinal pathology making the procedure difficult or dangerous to operate
- •Obese patient (BMI> 30kg / m2) with poorly perceived thoracic spinous processes.
- •vulnerable patients(Pregnant or breastfeeding women, persons benefiting from enhanced protection, namely persons deprived of their liberty by a judicial or administrative decision, adults under legal protection).
结局指标
主要结局
Pain assessment
时间窗: 6 hours from the end of the surgery
Pain assessment measured with Visual Analogue Scale (VAS) between 0 (no pain, best outcome) and 10 (worst possible pain, worst outcome) at mobility, (respiratory effort during peak flow meter measurement)
次要结局
- Efficacy of the block (a)(During the surgery)
- Efficacy of the block (b)(During the surgery)
- Efficacy of the block (c)(During the surgery)
- Intraoperative sufentanil consumption(During the surgery)
- Postoperative pain assessment(3, 6, 12, 24, 48 hours from the end of the surgery)
- Postoperative Morphine consumption(3, 6, 12, 24, 48 hours from the end of the surgery)
- Side effects associated to morphine(3, 6, 12, 24, 48 hours from the end of the surgery)
- Complication(s) associated to the procedure(48 hours from the end of the surgery)