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

University of Indonesia (UI)

Status: Completed

Conditions: Cortisol; Interleukin-6

Treatments: Procedure: Bilateral transversus thoracis muscle plane block; Procedure: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT04544254

IndonesiaUAnes056

Details and patient eligibility

About

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

Full description

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.

Enrollment: 32 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

Bilateral transversus thoracis muscle plane block

Active Comparator group

Description:

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

Treatment:

Procedure: Bilateral transversus thoracis muscle plane block

Control

Placebo Comparator group

Description:

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

Treatment:

Procedure: Control