The Analgesic Effect of Ultrasound Guided Bilateral Pecto Intercostal Fascial Plane Block on Sternal Wound Pain After Open Heart Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Cumulative morphine consumption
研究概览
简要总结
The objective is to test the effect of pecto intercostal fascial plane block (PIFB) as regard its impact on pain after sternotomy involved open heart surgery. The authors hypothesize that bilateral PIFB can reduce pain resulting from sternotomy following open heart surgeries.
详细描述
Pain following cardiac surgery is caused by many factors; sternotomy, chest wall retraction, opening of the pericardium, internal mammarian artery harvesting, saphenous vein harvesting, surgical manipulation of the parietal pleura, chest tube insertion and other musculoskeletal trauma occurring during surgery.
The pain following cardiac surgery is mainly attributed to sternotomy, with its peak during the first two days after the operation. Poststernotomy pain is not well tolerated by patients and may be accompanied by adverse postoperative events including delirium, hypertension, tachycardia, arrhythmia, respiratory complications, and persistent postsurgical pain.
Commonly pain management after cardiac surgery has been achieved using opiate analgesics. However, opiates have some dose-related side-effects such as nausea, constipation, vomiting, dizziness, mental confusion and respiratory depression, which may influence patient recovery and may delay discharge after surgery.
The pecto-intercostal fascial block (PIFB) was recently introduced by de la Torre et al for anesthesia during breast surgery. Local anesthetic is infiltrated into the interfascial plane separating pectoralis major and the intercostal muscles lateral to the sternum to anesthetize the anterior cutaneous branches of the intercostal nerves.
The pecto-intercostal fascial plane block can cover anterior branches of the intercostal nerves from the 2nd to 6th dermatomes with a single injection bilaterally, same as the transversus thoracic muscle plane block .
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
- Triple (Participant, 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
- 否
入选标准
- •Patients scheduled for elective cardiovascular surgery for coronary artery bypass grafting or valve replacement involving median sternotomy
排除标准
- •Patients with emergency surgeries.
- •Allergy to drug used.
- •Patients with prolonged Cardio-Pulmonary Bypass time (>120 min).
- •Preoperative poor left ventricular function (ejection fraction <40%).
- •Body Mass Index >
- •Systemic infections or infections at site of injection.
- •Prolonged ICU stay over 24 hours for different reasons i.e.re-do surgery, heart failure etc.
研究组 & 干预措施
PIFB group
For carrying out PIFB bilaterally the skin on either side of the sternum will be prepared with povidone iodine solution. Then a linear ultrasound probe will be placed on the right and left sides at 2 cm from the sternal body.
A 22 gauge, 4 inch needle will be advanced until contacting the 4th costal cartilage following the lower edge of US probe, directing the tip from the bottom of the sternum and positioning the needle tip between the pectoralis major and the external intercostal muscles. Group A will receive twenty milliliters of a solution of 0.25% bupivacaine plus epinephrine (5 mcg/ml). Boluses of 5 ml are introduced to perform hydrodissection of the interfascial plane.
干预措施: ultrasound (Device)
PIFB group
For carrying out PIFB bilaterally the skin on either side of the sternum will be prepared with povidone iodine solution. Then a linear ultrasound probe will be placed on the right and left sides at 2 cm from the sternal body.
A 22 gauge, 4 inch needle will be advanced until contacting the 4th costal cartilage following the lower edge of US probe, directing the tip from the bottom of the sternum and positioning the needle tip between the pectoralis major and the external intercostal muscles. Group A will receive twenty milliliters of a solution of 0.25% bupivacaine plus epinephrine (5 mcg/ml). Boluses of 5 ml are introduced to perform hydrodissection of the interfascial plane.
干预措施: Bupivacaine Hydrochloride 5 MG/ML (Drug)
结局指标
主要结局
Cumulative morphine consumption
时间窗: 24 hours postoperative
in milligram
次要结局
- hospital stay(1 minute after ICU admission up to 2 days)
- postoperative sternal wound pain degree(24 hours after extubation)
- diastolic blood pressure(1 minute after admission in ICU then every 4 hours for 6 times then every 8 hours for 3 times)
- partial pressure of oxygen(12 hour after extubation)
- Heart rate(1 minute before induction of anesthesia, 5 minutes after induction of anesthesia then every 30 minutes for 8 times)
- systolic blood pressure(1 minute after admission in ICU then every 4 hours for 6 times then every 8 hours for 3 times)
- peripheral oxygen saturation(1 minute after admission in ICU then every 4 hours for 6 times then every 8 hours for 3 times)
- incidence of Myocardial infarction(1 minute after ICU admission)
- incidence of postoperative pericardial effusion(1 minute after ICU admission)
- incidence of heart failure requiring inotropic support(1 minute after ICU admission)
- incidence of atrial fibrillation(1 minute after ICU admission)
- incidence of cerebral bleeding(1 minute after ICU admission up to 2 days)
- heart rate(1 minute after admission in ICU then every 4 hours for 6 times then every 8 hours for 3 times)
- incidence of cerebral stroke(1 minute after ICU admission up to 2 days)
- Gastrointestinal bleeding(1 minute after ICU admission up to 2 days)
- blood component requirements(1 minute after ICU admission up to 2 days)
- incidence of sternal complications.(1 minute after ICU admission up to 2 days)
研究者
Mohamed Ahmed Hamed
lecturer of anesthesia and intensive care
Fayoum University Hospital