Erector Spinae Plane (ESP) Block With 20 ml Versus 30 ml in Cardiac Surgery

Study Overview
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Brief Summary
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Even though erector spinae plane (ESP) block is shown to be efficient in cardiac surgery, it is still controversial how much volume is necessary for efficient analgesic effect for sternotomy and drain tube pain relief. This study aims to investigate the optimal local anesthetic volume (20 mL versus 30 mL) with ESP block for open-heart cardiac surgery.

Detailed Description
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In cardiac surgery, the most common cause of pain during the first two days postoperatively is median sternotomy. In a study in which 705 patients who had undergone cardiac surgery were followed up prospectively, postoperative 24 hours pain scores ranging from 5.3 to 6.5 out of 10 with deep breathing and coughing were shown. In these patients, it may increase the frequency of atelectasis due to reasons such as failure in pain control, weak coughing, and limitation of movement, and these may lead increase in morbidity and hospital stay. Although nonsteroidal analgesics and opioids are used successfully in the control of this severe pain, they are far from being ideal analgesics alone due to their side effects such as kidney damage, bleeding risk, sedation, respiratory depression, itching, nausea, and vomiting. The complications of neuraxial techniques seem to be the disadvantages of these methods. Erector spinae plane (ESP) block is one of the regional anesthesia techniques that has been shown to be effective in reducing sternotomy pain in sternotomy-guided cardiac surgeries. The Erector spinae plane (ESP) block was first described by Forero in 2016. In this block technique, a local anesthetic is given to the plane between the erector spinae muscle and the vertebral transverse process. The dorsal and ventral branches of the spinal nerves are blocked in this plane. However, due to individual regional anatomical differences, there is not enough data to determine the optimum volume at which the appropriate spread of local anesthetic will occur. Volume-based cadaver studies have some handicaps since they do not have the characteristics of living tissue. This study aims to compare the postoperative analgesic efficacy of ESP block applied at the same dose but with different local anesthetic volumes in cardiac surgeries to be performed with sternotomy.

Official Title
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Comparison of Postoperative Analgesic Efficacy of Erector Spinae Plane Block With 20 ml and 30 ml Bupivacaine Volumes in Cardiac Surgery

Conditions
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Cardiac Surgery, Postoperative Pain

Intervention / Treatment
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* Procedure: bilateral erector spinae plane block with 30 mL 0.25 % bupivacaine
* Procedure: bilateral erector spinae plane block with 20 mL 0.25 % bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients who will undergo coronary artery bypass grafting surgery with median sternotomy Exclusion Criteria: Emergency surgeries Patients with allergic reactions to anesthesia and analgesia drugs to be used Patients who do not want to participate in the study voluntarily Severe systemic disease (kidney, liver, pulmonary, endocrine) Substance abuse history History of chronic pain Psychiatric problems and communication difficulties Patients who need revision due to hemostasis in the postoperative period Patients with severe hemodynamic instability due to infection, heavy bleeding, etc.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ESP block with 20 mL local anesthetic solution<br>An erector spinae plane block will be performed at the level of the 5th thoracic vertebrae with 20 mL of 0.25% bupivacaine solution under ultrasound guidance before the operation. | Procedure: bilateral erector spinae plane block with 20 mL 0.25 % bupivacaine<br>* Preoperative, awake, bilateral, ultrasound-guided erector spinae plane block with 20 mL 0.25 % bupivacaine<br>* Other names: 20 mL;|
| Active Comparator: ESP block with 30 mL local anesthetic solution<br>An erector spinae plane block will be performed at the level of the 5th thoracic vertebrae with 30 mL of 0.25% bupivacaine solution under ultrasound guidance before the operation. | Procedure: bilateral erector spinae plane block with 30 mL 0.25 % bupivacaine<br>* Preoperative, awake, bilateral, ultrasound-guided erector spinae plane block with 30 mL 0.25 % bupivacaine<br>* Other names: 30 mL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-extubation 1st hour measurement | patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt. | 1 hour after endotracheal extubation, an average of 5 minutes | 
| Post-extubation 1st hour measurement | patients will be evaluated in terms of nausea and vomiting, if they have nausea or vomiting it will be recorded as nausea positive or vomiting positive, otherwise it will be recorded as negative. | 1 hour after endotracheal extubation, an average of 5 minutes | 
| Post-extubation 1st hour measurement | patients will be evaluated in terms of rescue analgesic, when patients have more than 4 visual analog score (VAS), they will be administered 1mg/kg tramadol and it will be recorded. | 1 hour after endotracheal extubation, an average of 5 minutes | 
| Post-extubation 2nd hour measurement | patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt. | 2 hour after endotracheal extubation, an average of 5 minutes | 
| Post-extubation 2nd hour measurement | patients will be evaluated in terms of nausea and vomiting, if they have nausea or vomiting it will be recorded as nausea positive or vomiting positive, otherwise it will be recorded as negative. | 2 hour after endotracheal extubation, an average of 5 minutes | 
| Post-extubation 2nd hour measurement | patients will be evaluated in terms of rescue analgesic, when patients have more than 4 visual analog score (VAS), they will be administered 1mg/kg tramadol and it will be recorded. | 2 hour after endotracheal extubation, an average of 5 minutes | 
| Post-extubation 4th hour measurement | patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt. | 4 hour after endotracheal extubation, an average of 5 minutes | 
| Post-extubation 4th hour measurement | patients will be evaluated in terms of nausea and vomiting, if they have nausea or vomiting it will be recorded as nausea positive or vomiting positive, otherwise it will be recorded as negative. | 4 hour after endotracheal extubation, an average of 5 minutes | 
| Post-extubation 4th hour measurement | patients will be evaluated in terms of rescue analgesic, when patients have more than 4 visual analog score (VAS), they will be administered 1mg/kg tramadol and it will be recorded. | 4 hour after endotracheal extubation, an average of 5 minutes | 
| Post-extubation 8th hour measurement | patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt. | 8 hour after endotracheal extubation, an average of 5 minutes | 
| Post-extubation 8th hour measurement | patients will be evaluated in terms of nausea and vomiting, if they have nausea or vomiting it will be recorded as nausea positive or vomiting positive, otherwise it will be recorded as negative. | 8 hour after endotracheal extubation, an average of 5 minutes | 
| Post-extubation 8th hour measurement | patients will be evaluated in terms of rescue analgesic, when patients have more than 4 visual analog score (VAS), they will be administered 1mg/kg tramadol and it will be recorded. | 8 hour after endotracheal extubation, an average of 5 minutes | 
| Post-extubation 12th hour measurement | patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt. | 12 hour after endotracheal extubation, an average of 5 minutes | 
| Post-extubation 12th hour measurement | patients will be evaluated in terms of nausea and vomiting, if they have nausea or vomiting it will be recorded as nausea positive or vomiting positive, otherwise it will be recorded as negative. | 12 hour after endotracheal extubation, an average of 5 minutes | 
| Post-extubation 12th hour measurement | patients will be evaluated in terms of rescue analgesic, when patients have more than 4 visual analog score (VAS), they will be administered 1mg/kg tramadol and it will be recorded. | 12 hour after endotracheal extubation, an average of 5 minutes | 
| Post-extubation 24th hour measurement | patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt. | 24 hour after endotracheal extubation, an average of 5 minutes | 
| Post-extubation 24th hour measurement | patients will be evaluated in terms of nausea and vomiting, if they have nausea or vomiting it will be recorded as nausea positive or vomiting positive, otherwise it will be recorded as negative. | 24 hour after endotracheal extubation, an average of 5 minutes | 
| Post-extubation 24th hour measurement | patients will be evaluated in terms of rescue analgesic, when patients have more than 4 visual analog score (VAS), they will be administered 1mg/kg tramadol and it will be recorded. | 24 hour after endotracheal extubation, an average of 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical ventilation duration | The total time until patients suitable for endotracheal extubation | postoperative, approximately 4 to 10 hours | 
| intensive care unit duration | The total time until patients suitable for discharge from intensive care unit | postoperative, approximately 12 to 36 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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erector spinae plane block, local anesthetic volume, bupivacaine, sternotomy