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Interleukin-6NCT04544254

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

A study testing Bilateral transversus thoracis muscle plane block in people with Interleukin-6 and Cortisol, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 19 to 75 years
Conditions the study is for
Interleukin-6, Cortisol
What is being tested?
Bilateral transversus thoracis muscle plane block
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteIndonesia
Study dates
15 Oct 2020to 15 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 19-75 years old
  • Patients who will undergo elective open heart surgery with median sternotomy approach

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • National General Hospital Dr. Cipto Mangunkusumo

    Jakarta, DKI Jakarta, 10430

Other trials in Indonesia

About this study

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

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

Read the 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.

Being tested
Bilateral transversus thoracis muscle plane block, Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bilateral transversus thoracis muscle plane blockProcedure or surgery

    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 or surgery

    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

Study groups in NCT04544254
Study groupRoleWhat they receive
Bilateral transversus thoracis muscle plane blockActive comparatorRegional 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
Receives: Procedure: Bilateral transversus thoracis muscle plane block
ControlPlacebo comparatorNeedle 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
Receives: Procedure: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Interleukin-6 plasma concentration

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

    Measured: 48 hours

  2. Cortisol plasma concentration

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

    Measured: 48 hours

Secondary outcomes (2)

  1. total morphine dose

    investigators will record total morphine dose needed in 24 hours

    Measured: 24 hours

  2. time to first morphine

    investigators will record time to first morphine dose after surgery

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2020
  2. Study start15 Oct 2020
  3. Primary completion15 Mar 2021
  4. Study completion15 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04544254
Sponsor's protocol ID
IndonesiaUAnes056
Status last verified
Nov 2021
First submitted
29 Aug 2020
Last updated
8 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Raksamani K, Wongkornrat W, Siriboon P, Pantisawat N. Pain management after cardiac surgery: are we underestimating post sternotomy pain? J Med Assoc Thai. 2013 Jul;96(7):824-8.

    PubMed 24319854

  • Roca J, Valero R, Gomar C. Pain locations in the postoperative period after cardiac surgery: Chronology of pain and response to treatment. Rev Esp Anestesiol Reanim. 2017 Aug-Sep;64(7):391-400. doi: 10.1016/j.redar.2017.01.002. Epub 2017 Feb 22. English, Spanish.

    PubMed 28237371

  • Mello LC, Rosatti SF, Hortense P. Assessment of pain during rest and during activities in the postoperative period of cardiac surgery. Rev Lat Am Enfermagem. 2014 Jan-Feb;22(1):136-43. doi: 10.1590/0104-1169.3115.2391.

    PubMed 24553714

  • Li X, Feng Y, Yang BX. Postoperative pain after cardiac surgery. J Cardiothorac Vasc Anesth. 2010 Dec;24(6):1025-6. doi: 10.1053/j.jvca.2010.01.009. Epub 2010 Apr 22. No abstract available.

    PubMed 20417122

  • Zubrzycki M, Liebold A, Skrabal C, Reinelt H, Ziegler M, Perdas E, Zubrzycka M. Assessment and pathophysiology of pain in cardiac surgery. J Pain Res. 2018 Aug 24;11:1599-1611. doi: 10.2147/JPR.S162067. eCollection 2018.

    PubMed 30197534

  • Mazzeffi M, Khelemsky Y. Poststernotomy pain: a clinical review. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):1163-78. doi: 10.1053/j.jvca.2011.08.001. Epub 2011 Sep 29. No abstract available.

    PubMed 21955825

  • Huang AP, Sakata RK. Pain after sternotomy - review. Braz J Anesthesiol. 2016 Jul-Aug;66(4):395-401. doi: 10.1016/j.bjane.2014.09.013. Epub 2016 Apr 23.

    PubMed 27343790

  • Jellish WS, Oftadeh M. Enhanced Recovery After Surgery for Cardiac Surgery: Will We Have the Techniques Needed to Reduce Opioid Use and Still Provide Appropriate Analgesia? J Cardiothorac Vasc Anesth. 2019 Feb;33(2):547-548. doi: 10.1053/j.jvca.2018.10.022. Epub 2018 Oct 24. No abstract available.

    PubMed 30477887

  • Wong WT, Lai VK, Chee YE, Lee A. Fast-track cardiac care for adult cardiac surgical patients. Cochrane Database Syst Rev. 2016 Sep 12;9(9):CD003587. doi: 10.1002/14651858.CD003587.pub3.

    PubMed 27616189

  • Jaya AAGPS, Tantri AR, Heriwardito A, Mansjoer A. Single-centre, double-blind, randomised, parallel-group, superiority study to evaluate the effectiveness of general anaesthesia and ultrasound-guided transversus thoracis muscle plane block combination in adult cardiac surgery for reducing the surgical stress response: clinical trial protocol. BMJ Open. 2021 Nov 11;11(11):e051008. doi: 10.1136/bmjopen-2021-051008.

    PubMed 34764171

Questions about this trial

What is this clinical trial studying?

A study testing Bilateral transversus thoracis muscle plane block in people with Interleukin-6 and Cortisol, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Interleukin-6 plasma concentration (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04544254, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.

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