Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Morphine Consumption
  • Pain Postoperative
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Investigator)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Description

99 patients will be included in the study. Group C (Control, n = 31), Group ES (Erector Spina, n = 31), Group PV (Paravertebral n = 31) will be randomized. A researcher will present the patient distribution to patients in a sealed envelope (1: 1: 1 distribution ratio). This envelope will be opened i...

99 patients will be included in the study. Group C (Control, n = 31), Group ES (Erector Spina, n = 31), Group PV (Paravertebral n = 31) will be randomized. A researcher will present the patient distribution to patients in a sealed envelope (1: 1: 1 distribution ratio). This envelope will be opened in the preoperative preparation room. 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: ESP (Erector Spina Plane) Block Group 2. Parasternal Block Group 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 ?g / 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

Tracking Information

NCT #
NCT04090099
Collaborators
Not Provided
Investigators
Principal Investigator: yavuz orak, md Kahramanmara? Sutcu Imam University Faculty of Medicine