Transversus Thoracis Muscle Plane Block for Postoperative Pain in Adult Cardiac Surgery

Postoperative Pain Clinical Trial

Official title:

Bilateral Transversus Thoracis Muscle Plane Block for Acute Postoperative Pain in Adult Coronary Artery Bypass Graft Surgery: A Randomized Controlled Observer Blinded Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04591119
• Other study ID #: MSKU 20-IV
• Status: Completed
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: December 21, 2020

Study information

• Verified date: November 2023
• Source: Mugla Sitki Koçman University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Inadequate pain control after coronary artery bypass graft surgery increases mortality and results in a higher incidence of persistent poststernotomy pain syndrome. Our aim is to assess whether ultrasound-guided parasternal intercostal block (PSIB) or surgeon implied transversus thoracic muscle plane block (TTMPB) would improve the postoperative pain scores and decrease tramadol consumption better after coronary artery bypass graft surgery

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 21, 2020
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists physical status II-III

• Elective coronary artery bypass graft surgery under general anesthesia

Exclusion Criteria:

• American Society of Anesthesiologists physical status IV

• Emergency surgery and redo surgery

• Low cardiac output syndrome, perioperative intra-aortic balloon pump support for any reason, bleeding disorder or abnormal coagulation profile, abnormal hepatic and renal parameters, uncontrolled diabetes mellitus, chronic obstructive pulmonary disease, atrial fibrillation on anticoagulation

• Allergy to any study drugs, local infection at the block site

• Opioid abuse

Related Conditions & MeSH terms

• Chest Pain
• Coronary Artery Bypass
• Pain, Postoperative
• Postoperative Pain
• Sternotomy

Intervention

Procedure:
• Transversus Thoracic Muscle Plane Block
40 ml %0.375 bupivacaine divided into 4 equal doses will be injected by the surgeon between internal intercostal muscle and transversus thoracis muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space
• Parasternal Intercostal Plane Block
40 ml %0.375 bupivacaine injection will be performed by ultrasound guidance after completion of surgery between pectoralis major muscle and external intercostal muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space bilaterally by anesthesiologist.

Locations

Country	Name	City	State
Turkey	Mugla Sitki Kocman University Training nad research Hospital	Mugla

Sponsors (1)

Lead Sponsor	Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

de la Torre PA, Garcia PD, Alvarez SL, Miguel FJ, Perez MF. A novel ultrasound-guided block: a promising alternative for breast analgesia. Aesthet Surg J. 2014 Jan 1;34(1):198-200. doi: 10.1177/1090820X13515902. No abstract available. — View Citation

Ueshima H, Takeda Y, Ishikawa S, Otake H. RETRACTED: Ultrasound-guided transversus thoracic muscle plane block: a cadaveric study of the spread of injectate. J Clin Anesth. 2015 Dec;27(8):696. doi: 10.1016/j.jclinane.2015.05.013. Epub 2015 Jul 3. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative opioid consumption	Tramadol consumption will be assessed by checking patient daily drug order records	Postoperative 24th hour
Primary	Postoperative opioid consumption	Tramadol consumption will be assessed by checking patient daily drug order records	Postoperative 1st, 4th and 12th hour
Secondary	Behavioral Pain Scale	A blinded nurse will assess postoperative pain while they are intubated at the 1st and 4th hour by using 3 subscale Behavioral Pain Scale which ranges from 3 (no pain) to 12 (maximum pain)	postoperative 1st and 4th hour
Secondary	Numeric Rating Scale	A blinded nurse will assess postoperative pain during resting and movement at postoperative 12th and 24th hour by using Numeric rating scale at the extubated patient by using 11-point Numerical Rating Scale which ranges from '0' (means no pain) to '10' (means worst pain imaginable)	Postoperative 12th and 24th hour