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

Indonesia University32 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Interleukin-6 Cortisol

Interventions

Bilateral transversus thoracis muscle plane blockPROCEDURE

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.

ControlPROCEDURE

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

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Age 19-75 years old 2. Patients who will undergo elective open heart surgery with median sternotomy approach Exclusion criteria: 1. Patient who does not agree to be included in this study 2. weight \<45kg or \>75 kg 3. Patient with chronic obstructive pulmonary disease 4. Patient with chronic kidney disease who needs regular hemodialysis. 5. Patient with local infection in the injection area for transversus thoracis muscle plane block 6. Patient with chronic pain 7. Patient with history of chronic analgetics drugs usage 8. Patient who is contraindicated for local anesthetics 9. Patient with communication disability 10. Patient with cognitive disorders 11. Patient with severe psychiatrics disorders, such as schizophrenia and bipolar disorder

Locations (1)

National General Hospital Dr. Cipto Mangunkusumo

Jakarta, DKI Jakarta, Indonesia

Outcomes

Primary Outcomes

Interleukin-6 plasma concentration

Interleukin-6 plasma concentration will be measured 3 times, before surgery, 24 hours after surgery, and 48 hours after surgery

Time frame: 48 hours

Cortisol plasma concentration

cortisol plasma concentration will be measured 3 times, before surgery, 24 hours after surgery, and 48 hours after surgery

Time frame: 48 hours

Secondary Outcomes

total morphine dose

investigators will record total morphine dose needed in 24 hours

Time frame: 24 hours

time to first morphine

investigators will record time to first morphine dose after surgery

Time frame: 24 hours

Data from ClinicalTrials.gov

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