Effectivity of Bilateral Transversus Thoracis Muscle Plane Block After Open Heart Surgery

Study Overview
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Brief Summary
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This Study aimed to assess The Effectivity of Bilateral Transversus Thoracis Muscle Plane Block to Reduce Pain and Stress Response After Open Heart Surgery

Detailed Description
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This is a double blind randomized controlled trial. Thirty-two subject will be recruited with non-probability consecutive sampling method. Subjects who meet all inclusion criteria and do not have exclusion criteria will be asked to sign the informed consent form before included in this study. Subjects will be randomized into two groups. The first group is the treatment group who will get Bilateral Transversus Thoracis Muscle Plane Block after induction of anesthesia and the second group will be the control group who will not get any regional block during surgery. After surgery, time to first morphine dose, total morphine consumption in 24 hours, extubation time, and adverse events will be recorded for both group.

Official Title
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Effectivity of Bilateral Transversus Thoracis Muscle Plane Block to Reduce Pain and Stress Response After Open Heart Surgery: A Study to Interleukin-6 and Cortisol Plasma Concentration, Total Opioid Dose, and Time to First Opioid

Conditions
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Interleukin-6, Cortisol

Intervention / Treatment
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* Procedure: Bilateral transversus thoracis muscle plane block
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age 19-75 years old Patients who will undergo elective open heart surgery with median sternotomy approach Exclusion criteria: Patient who does not agree to be included in this study weight <45kg or >75 kg Patient with chronic obstructive pulmonary disease Patient with chronic kidney disease who needs regular hemodialysis. Patient with local infection in the injection area for transversus thoracis muscle plane block Patient with chronic pain Patient with history of chronic analgetics drugs usage Patient who is contraindicated for local anesthetics Patient with communication disability Patient with cognitive disorders Patient with severe psychiatrics disorders, such as schizophrenia and bipolar disorder

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bilateral transversus thoracis muscle plane block<br>Regional block will be performed after induction of anesthesia by anesthesiologist on duty who is not part of investigators for this study. The block will be performed in between intercostal space 4 and 5, lateral from sternum, with ultrasound guided | Procedure: Bilateral transversus thoracis muscle plane block<br>* The block will be performed in between intercostal space 4 and 5, lateral from sternum, with ultrasound guided. Twenty milliliters bupivacaine 0.5% 1mg/body weight will be injected between internal intercostal muscle and transversus thoracis muscle on both sides.<br>|
| Placebo Comparator: Control<br>Needle will be put in the superficial skin on the same area as transversus thoracis muscle plane block area without any drugs injected into the injection area | Procedure: Control<br>* A needle will be place in the similar area to the transversus thoracis muscle plane block, but no drugs will be injected to the area<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin-6 plasma concentration | Interleukin-6 plasma concentration will be measured 3 times, before surgery, 24 hours after surgery, and 48 hours after surgery | 48 hours | 
| Cortisol plasma concentration | cortisol plasma concentration will be measured 3 times, before surgery, 24 hours after surgery, and 48 hours after surgery | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total morphine dose | investigators will record total morphine dose needed in 24 hours | 24 hours | 
| time to first morphine | investigators will record time to first morphine dose after surgery | 24 hours |