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

NCT04591119 | Completed

• 1 other identifier: MSKU 20-IV
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Postoperative Pain; Chest Pain; Coronary Artery Bypass; Sternotomy

Keywords

adult cardiac surgery; poststernotomy pain; transversus thoracic muscle plane block; parasternal intercostal block; behavioral pain scale; numeric rating scale

Outcome Measures

Primary Outcomes (2)

• Postoperative opioid consumption

  Tramadol consumption will be assessed by checking patient daily drug order records

  Postoperative 24th hour

• Postoperative opioid consumption

  Tramadol consumption will be assessed by checking patient daily drug order records

  Postoperative 1st, 4th and 12th hour

Secondary Outcomes (2)

• Behavioral Pain Scale

  postoperative 1st and 4th hour

• Numeric Rating Scale

  Postoperative 12th and 24th hour

Study Arms (3)

Transversus Thoracic Muscle Plane Block (TTMPB) Group

ACTIVE COMPARATOR

At the TTMPB group, the block will be performed by the surgeon before the closure of the sternum by visualizing the muscles and identifying them. In the TTMPB group patients will receive 40 ml %0.375 bupivacaine divided into 4 equal doses between internal intercostal muscle and transversus thoracic muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space.

Procedure: Transversus Thoracic Muscle Plane Block

Parasternal Intercostal Block (PSIB) Group

ACTIVE COMPARATOR

At the PSIB group, the block will be performed by ultrasound guidance after completion of surgery. PSIB Blocks will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesist.In PSIB group patients will receive 40 ml %0.375 bupivacaine divided into 4 equal doses between psoas major muscle and external intercostal muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space bilaterally.

Procedure: Parasternal Intercostal Plane Block

Control Group

NO INTERVENTION

At the control group, no intervention for pain management will be done.

Interventions

Transversus Thoracic Muscle Plane Block PROCEDURE

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

Transversus Thoracic Muscle Plane Block (TTMPB) Group

Parasternal Intercostal Plane Block PROCEDURE

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.

Parasternal Intercostal Block (PSIB) Group

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists physical status II-III
• Elective coronary artery bypass graft surgery under general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Mugla Sıtkı Kocman University Training nad research Hospital

Muğla, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 26144912 BACKGROUND

• 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.

  PMID: 24396082 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Chest Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Melike Korkmaz Toker, Assist.Prof

  Mugla Sıtkı Kocman University Department of Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 11, 2020
• First Posted: October 19, 2020
• Study Start: October 20, 2020
• Primary Completion: December 20, 2020
• Study Completion: December 21, 2020
• Last Updated: December 5, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)