Erector Spinae Plane Block Versus Its Combination With Superficial Parasternal Intercostal Plane Block for Postoperative Pain After Cardiac Surgery: A Prospective, Randomized, Double-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Morphine consumption in the first 24 hours after surgery
研究概览
简要总结
Cardiac surgery is associated with significant postoperative pain. Pain control is an essential part of enhanced recovery protocols. The aim of this study is to evaluate and compare the analgesic efficacies of erector spinae plane block (ESPB) and the combination of ESPB and superficial parasternal intercostal plane block (PIPB) in patients undergoing elective cardiac surgery.
详细描述
Many regional techniques have been used to manage postoperative pain in cardiac surgery, including thoracic epidural anesthesia, paravertebral, intercostal nerve block, intrathecal spinal morphine, and local infiltration. Increased risk of epidural/spinal hematoma secondary to systemic heparinization, potential hemodynamic instability, technical difficulties and complications such as pneumothorax are potential serious drawbacks. Due to the aforementioned reasons, anesthetists are understandably preferring ultrasound (US) guided interfascial plane blocks, which are generally thought to provide safer and more effective analgesia in cardiac surgery.
This study aims to evaluate and compare the effects of ESPB versus ESPB plus Superficial PIPB on pain scores and opioid consumption in patients undergoing elective cardiac surgery.
Patients will be divided into two groups:
Group ESPB:
In this group, patients will be administered bilateral ESPB (total of 40 ml, %0.25 bupivacaine) in addition to IV morphine patient-controlled analgesia (PCA) for the first 24 postoperative hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sealed opaque envelopes containing study participation numbers will be used for the purpose of assigning each patient. A researcher not involved in patient followup will use the web based "Research Randomizer'' (Urbaniak and Plous 2013) tool in order to assign each participation number into a random group with a 1:1 ratio.
A nurse that is not an active investigator in the study will have each participant choose an envelope that contains the study participation number. An assistant not active in the study will inform the anesthetist who will administer the block/blocks about which group the patient is in, immediately prior to administration. Researchers, patients, surgeons, and nurses will not be aware of the randomization of groups.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) 2-3 patients between the ages of 18-80 who are scheduled for elective cardiac surgery (coronary artery bypass graft surgery +/- valve replacement or isolated valve surgery)
- •BMI <35 kg / m2
排除标准
- •Emergent surgeries, redo cases, minimally invasive procedures
- •Patients who do not want to participate
- •Patients with cognitive dysfunction (patients who are not able to evaluate the verbal numerical pain scale)
- •Hypersensitivity or history of allergies to local anesthetics
- •Major liver or kidney dysfunction or other pre-existing major organ dysfunction
- •Left ventricular ejection fraction <30
- •Individuals with mental health disorders (for example bipolar disorder or depression)
- •Pregnancy or breastfeeding
- •Presence of hematological disease
- •Patients with alcohol-drug addiction
结局指标
主要结局
Morphine consumption in the first 24 hours after surgery
时间窗: Postoperative day 1
Morphine consumption in the first 24 hours will be measured. Patients will be able to request opioids via a PCA device when their NRS score ≥4.
次要结局
- Postoperative pain scores(Postoperative day 1)
- Time to extubation(Postoperative day 1)
- The number of patient requiring rescue analgesic(Postoperative Day 1)
- The incidences of post-operative nausea and vomiting (PONV)(Postoperative Day 1)
- Patient satisfaction as measured by the Revised American Pain Society Patient Outcome Questionnaire(Postoperative Day 1)
- The number of patients with complications(Postoperative 7 days on an average)
研究者
BURHAN DOST
Associate Professor
Ondokuz Mayıs University