Clinical trial NCT04090099: Bilateral Erector Spina Block Versus Parasternal Block in Adult Heart Surgery
Official title: Ultrasound-GTrialuided Bilateral Erector Spina Block Versus Parasternal Block in Adult Cardiac Surgery: A Prospective, Randomized, Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morphine Consumption
Pain, Postoperative
Keywords: Erector Spinae Block, Parasternal block, Cardiac surgery
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2019-09-16
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Inadequate pain relief after cardiac surgery increases morbidity and results in a high incidence of persistent poststernotomy pain syndrome. The use of special opioid-based analgesia causes adverse effects such as nausea, vomiting, sedation, urinary retention, respiratory depression and delayed tracheal extubation. Regional anesthesia techniques such as pectoralis nerve block and serratus anterior block provide analgesia in the sternum and pain relief in the lateral / posterior chest Wall. Erector spinae (ESP) block, a new and simple myofascial block, provides wide multi-dermatomal sensory block. In the T5 spinous process, bilateral ESP block provides analgesia from T2 to T9 sensory level, resulting in both somatic and visceral analgesia by blocking both the dorsal and ventral of the spinal nerves, including the sympathetic chain. This block may provide adequate analgesia for median sternotomy because the main nerve supply to the sternal region is from T2 to T6. Median sternotomy incision and mediastinal tube regions are the major source of pain in patients undergoing cardiac surgery. The anterior and posterior branches of the intercostal nerves give nerves to the sternum. Parasternal local anesthetic infiltration around the sternum is effective in providing early postoperative analgesia and reducing opioid requirements and therefore has positive effects on healing. This simple and fast technique can be used even for anticoagulated patients.

Detailed description: 99 patients will be included in the study. Group C (Control, n = 31), Group ES (Erector Spina, n = 31), Group PS (Parasternal Intercostal Block n = 31) will be randomized. Randomization was achieved by randomly assigning patients to computer-generated random numbers. It will be explained that patients can receive both intravenous analgesia treatment and both blocks that are thought to be done. Patients will be told to express the degree of postoperative pain in the preoperative preparation room using a numerical scoring scale (NRS) between 0 and 10 (no pain at 0, no pain at 10). The vascular access will be opened in the pre-operative preparation room and 2 mg demizolam will be made. All preoperative cardiac drugs, except antiplatelet and anticoagulants, will be continued until the morning of surgery.

Demographic structures, cardiopulmonary bypass time, aortic cross clamp time, surgical time, ejection / fraction values will be recorded.

Weight and height of patients will be recorded (BMI). Preoperative, blood group and typing, full hemogram, liver function tests, renal function tests, chest radiography, electrocardiography, 2D transthoracic echocardiography and coronary angiography will be done as routine investigations.

Platelet count, bleeding time, clotting time, prothrombin time, activated partial thromboplastin time will be checked in all patients.

Constructional blocks:

1. ESP (Erector Spina Plane) Block Group
2. 2. Parasternal Block Group
3. Control Group The control group will not receive any Erector Spina block and Paravertebral Block. Only PCA (Patient Control Analgesia) and intravenous analgesic (Morphine) drug will be used.

The same surgical and anesthesia team will manage the patients. 6 channel ECG and non-invasive arterial pressure monitoring will be performed after the patients are admitted to the operation room. A peripheral intravenous line with a 16-gauge needle and a right radial artery with a 20-gauge needle will be performed. Blood will be taken for preoperative blood gas. Midazolam 0.01 (mg / kg), fentanyl (5-8 μg / kg) and rocuronium (0.6 mg / kg) will be used for induction of anesthesia. After anesthesia, central venous catheter and urinary catheter will be inserted. During general anesthesia Sevoflurane will be used in the air-oxygen mixture with a concentration of 50% oxygen. Normocapnic variation will be provided (PCO2 = 35-45). A rocuronium 0.6 mg / kg will be used every 30 minutes. All patients will undergo median sternotomy. Heparin 300-500 Units / kg to be administered. Activeted clotting time (ACT) will be kept\> 400 throughout the procedure. Esophageal temperature will be monitored. The mean arterial pressure throughout the operation will be maintained above 60 mm Hg. Peroperative blood sample will be taken from the radial artery 3-5 minutes after the cross-clamp is removed. Heparin will be neutralized with protamine 1: 1.3. After the operation, patients will be transferred to the intensive care unit.

In the intensive care unit, patients will be extubated when the respiratory effort occurs, when the patient is awake, blood gas values are within normal range, body temperature is normal and hemodynamically stable. Morphine consumption by PCA and NRS scores will be monitored and recorded at 1, 3, 6, 12 and 24 hours after extübation. MAP (Mean arterial pressure), PH, PO2 (Blood gas) follow-ups will be recorded in the first blood gas, extubation and postoperative 1,2, 4,6,12, 24 hours.Paracetamol 1 g and Tramadol 1mg/kg intravenously will be administered to the patient if NRS\> 3 when the patient is extubated.

If the patient's consciousness and hemodynamic status do not allow pain assessment, the patient will be excluded from the study. After the surgery, the investigator who evaluates NRS scores in the ICU will not know which group the patient is.

Oral feeding at postoperative hour, intensive care unit stay day, Side effects Nausea, Vomiting, Itching to be followed

Eligibility criteria: Inclusion Criteria:

* Male and / or female patients
* Aged 18-65 years
* Patients who will have coronary artery surgery under cardiopulmonary baypass (changing one, two and three vessels) with normal left ventricular function,
* Valve diseases with normal left ventricular function,
* ASD (Atrial Septal Defect) cases for atrial septal defect closure
* Patients with valve + CABG without left ventricular dysfunction will be included in the study.
* Ejection- Fraction\> 50-55

Exclusion Criteria:

* Emergency and repeat heart surgery cases
* Advanced left coronary artery disease and left ventricular dysfunction
* Receiving preoperative inotropic support therapy,
* With mitral stenosis with atrial tombus,
* With low cardiac out put syndrome,
* Need intra-aortic balloon pump during surgery,
* Bleeding and coagulation disorder,
* Liver and kidney dysfunction,
* Patients with uncontrolled diabetes mellitus and coronary artery pulmonary disease,
* Opioid, analgesic and bupivacaine allergy,
* Patients with atrial fbrilation using anticoagulants
* Patients with cognitive dysfunction
* Patients who do not want to participate in the study

Primary outcomes:
measure: Morphine consumption by PCA
timeFrame: Change from baseline 1 , 3, 6, 12 and 24 hours after extubation
Secondary outcomes:
measure: Change Pain Scores
timeFrame: Time Frame: 1 hour,3 hours, 6 hours, 12 hours, 24 hours after the extubation
measure: Change Blood Gas
timeFrame: Change from Baseline at 60 minutes,2 hours, 4 hours, 6 hours, 12 hours, 24 hours after extübation ,
measure: Blood Pressure
timeFrame: Change from Baseline at 60 minutes,2 hours, 4 hours, 6 hours, 12 hours, 24 hours after extübation ,
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaras Sutcu Imam Univercity Faculty of edicine
state: Onikişubat
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaras Sutcu Imam University Faculty of Medicine
state: Onikişubat
Study officials:
affiliation: Kahramanmaraş Sutcu Imam University Faculty of Medicine
name: yavuz orak, md
role: PRINCIPAL_INVESTIGATOR
References: