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Completed

NCT Number: NCT04544254

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

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

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Key information

Conditions

Interleukin-6 Cortisol

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National General Hospital Dr. Cipto Mangunkusumo

Jakarta, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bilateral transversus thoracis muscle plane block

Procedure

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.

Control

Procedure

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

Primary outcomes

  1. Interleukin-6 plasma concentration

    Time frame: 48 hours

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

  2. Cortisol plasma concentration

    Time frame: 48 hours

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

Secondary outcomes

  1. total morphine dose

    Time frame: 24 hours

    investigators will record total morphine dose needed in 24 hours

  2. time to first morphine

    Time frame: 24 hours

    investigators will record time to first morphine dose after surgery

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 10, 2020
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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