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

NCT04544254 | Completed DMC

• 1 other identifier: IndonesiaUAnes056
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Interleukin-6; Cortisol

Outcome Measures

Primary Outcomes (2)

• Interleukin-6 plasma concentration

  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

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

  48 hours

Secondary Outcomes (2)

• total morphine dose

  24 hours

• time to first morphine

  24 hours

Study Arms (2)

Bilateral transversus thoracis muscle plane block

ACTIVE COMPARATOR

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

Control

PLACEBO COMPARATOR

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

Interventions

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.

Bilateral transversus thoracis muscle plane block

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

Control

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

National General Hospital Dr. Cipto Mangunkusumo

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Related Publications (10)

• 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.

  PMID: 24319854 BACKGROUND

• 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.

  PMID: 28237371 BACKGROUND

• 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.

  PMID: 24553714 BACKGROUND

• 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.

  PMID: 20417122 BACKGROUND

• 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.

  PMID: 30197534 BACKGROUND

• 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.

  PMID: 21955825 BACKGROUND

• 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.

  PMID: 27343790 BACKGROUND

• 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.

  PMID: 30477887 BACKGROUND

• 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.

  PMID: 27616189 BACKGROUND

• 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.

  PMID: 34764171 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: September 10, 2020
• Study Start: October 15, 2020
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: November 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)