Efficacy of Ultrasound-guided Bilateral Transversus Thoracic Muscle Plane Block as Postoperative Analgesia in Adult Patients Undergoing Open Heart Surgeries: a Randomized Controlled Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Total opioid consumption
研究概览
简要总结
OPEN CARDIAC SURGERY may cause severe postoperative pain and promote a high risk of chronic pain if not treated adequately, that is caused by multiple factors; sternotomy, costotransverse and costovertebral joint distensions, opening of the pericardium, internal mammarian artery harvesting, surgical manipulation of the parietal pleura, chest tube insertion and other musculoskeletal trauma that occurs during surgery.
Adequate analgesia is important not only for patient comfort, but for weaning from ventilator and prevention of respiratory complications. Opioids are used to provide analgesia, but they are associated with significant side effects which include sedation, respiratory depression, nausea, and vomiting.
Severe sternotomy pain in cardiac surgery has been reported in up to 49% of patients at rest and 78% at movement. Of the various options for postoperative pain relief in cardiac surgery, we have chosen an ultrasound-guided transversus thoracic muscle plane (TTP) block versus sham block performed by the anesthesiologist.
Transversus thoracic muscle plane (TTP) block and The pecto-intercostal fascial plane block can block multiple anterior branches of the intercostal nerves (T2 to 6), which dominate the internal mammary region with a single injection bilaterally.
详细描述
After approval of the institutional ethics committee and written informed consent, (70) patients scheduled for open heart surgery including valve replacement or adult congenital (ASD or VSD) in Fayoum university hospital from May 2019 to November 2020 will be enrolled in this randomized prospective double blinded study.
Patients will be divided into two groups randomized by computer generated random numbers that will be placed in separate opaque envelopes that will be opened by study investigators just before the block.Neither the participants, the study investigators, the attending clinicians, nor the data collectors will be aware of groups' allocation until the study end. The Consolidated Standards of Reporting Trials (CONSORT) recommendations for reporting randomized, controlled clinical trials will be followed.
Group A which will have an ultrasound-guided bilateral transversus thoracic muscle plane (TTP) block.
Group B which will have sham block bilaterally. All patients will be preoperatively examined and investigated by complete blood count, coagulation profile, renal and kidney functions and electrolytes. Electrocardiography, chest x ray and echocardiography will be routinely done. Coronary angiography and carotid arterial duplex will be requested on demand.
Patient will be premedicated by intramuscular injection of 10mg morphine at morning of the operation. Before induction of anesthesia, a five-lead electrocardiography system will be applied to monitor heart rate, rhythm, and ST segments (leads II and V5). A pulse oximeter probe will be attached, and a peripheral venous cannula will be placed. For measurement of arterial pressure and blood sampling, a 20 G cannula will be inserted into either right or left radial artery under local anesthesia. After pre-oxygenation, general anesthesia will be induced by midazolam 2-5 mg, fentanyl (10μg/kg), propofol (3-4mg/Kg), followed by atracurium (0.5 mg/kg).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 18 years of age or older (18 - 80 yrs. old).
- •Scheduled for elective cardiac surgery for valve replacement or adult congenital (VSD or ASD) via median sternotomy.
排除标准
- •Patients with emergency surgeries.
- •Allergy to drug used.
- •re-do surgery.
- •Coagulopathy.
- •Neuromuscular disease.
- •Preoperative poor left ventricular function (EF < 35%).
- •Systemic infections or infections at site of injection.
- •Psychiatric illnesses (schizophrenia, bipolar, uncontrolled anxiety or depression).
- •Narcotic dependency.
研究组 & 干预措施
intervention group (A)
which will have an ultrasound-guided bilateral transversus thoracic muscle plane (TTP) block by injection of 20 mL of 0.25% bupivacaine and the same procedure will be repeated on the other side.
干预措施: 0.25% bupivacaine. (Drug)
control group (B)
which will have sham block bilaterally by injection of 20 ml of 0.9%saline will be injected on each side.
干预措施: 0.9%saline (Device)
结局指标
主要结局
Total opioid consumption
时间窗: from the time of ICU admission hour 1 up to 24 hour
the amount of opioid (mostly used is fentanyl amp. in equivalent doses ) that has been used for 24 hours after admission in ICU
次要结局
未报告次要终点
研究者
Mohamed Ahmed Hamed
Lecturer of Anesthesiology
Fayoum University