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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04544254
Recruitment Status : Completed
First Posted : September 10, 2020
Last Update Posted : November 8, 2021
Sponsor:
Information provided by (Responsible Party):
Aida Rosita Tantri, Indonesia University

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

Condition or disease Intervention/treatment Phase
Interleukin-6 Cortisol Procedure: Bilateral transversus thoracis muscle plane block Procedure: Control Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 15, 2020
Actual Primary Completion Date : March 15, 2021
Actual Study Completion Date : March 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04544254


Locations
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Indonesia
National General Hospital Dr. Cipto Mangunkusumo
Jakarta, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Aida Rosita Tantri, Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier: NCT04544254    
Other Study ID Numbers: IndonesiaUAnes056
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: November 8, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No