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

November 1, 2021 updated by: Aida Rosita Tantri, Indonesia University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 10430
        • National General Hospital Dr. Cipto Mangunkusumo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bilateral transversus thoracis muscle plane block
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
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.
Placebo Comparator: Control
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 hours
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
48 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2020

Primary Completion (Actual)

March 15, 2021

Study Completion (Actual)

March 15, 2021

Study Registration Dates

First Submitted

August 29, 2020

First Submitted That Met QC Criteria

September 3, 2020

First Posted (Actual)

September 10, 2020

Study Record Updates

Last Update Posted (Actual)

November 8, 2021

Last Update Submitted That Met QC Criteria

November 1, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • IndonesiaUAnes056

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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