MedDataX Logo

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

NCT ID: NCT04544254

Last Updated: 2021-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2021-03-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Interleukin-6 Cortisol

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Bilateral transversus thoracis muscle plane block

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Control

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Indonesia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aida Rosita Tantri

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National General Hospital Dr. Cipto Mangunkusumo

Jakarta, DKI Jakarta, Indonesia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Indonesia

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24319854 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28237371 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24553714 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20417122 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30197534 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21955825 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27343790 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30477887 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27616189 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34764171 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IndonesiaUAnes056

Identifier Type: -

Identifier Source: org_study_id