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

Cortisol Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04544254
• Other study ID #: IndonesiaUAnes056
• Status: Completed
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: March 15, 2021

Study information

• Verified date: November 2021
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 15, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cortisol
• Interleukin-6

Intervention

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.
• 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

Locations

Country	Name	City	State
Indonesia	National General Hospital Dr. Cipto Mangunkusumo	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (9)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. English, Portuguese, Spanish. — View Citation

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. — View Citation

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. — View Citation

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:CD003587. doi: 10.1002/14651858.CD003587.pub3. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	total morphine dose	investigators will record total morphine dose needed in 24 hours	24 hours
Secondary	time to first morphine	investigators will record time to first morphine dose after surgery	24 hours