Ultrasound-guided Modified Transversus Thoracic Muscle Plane Block and Erector Spinal Muscle Plane Block in Heart Valve Replacement Surgery With Median Incision

Sternum midline incision can offer better view under open-heart surgery and bigger operating space, and therefore it has been widely used in most cardiac surgery. If an event of urgency occurs, it takes on a more important role than infrasternal small incision. However, sternum midline incision may cause serious pain and aggravates stress response, and therefore patients are often reluctant to cooperate to cough which exerts adverse effect on postoperative rehabilitation, and even causes serious complications such as pulmonary inflammation, myocardial infarction and heart failure. Thus, the relief of pain and better perioperative analgesia are very important for these patients. Transversus thoracic muscle plane(TTMP) block and erector spinal muscle plane(ESP) block are used in open heart surgery currently, and they can provide good analgesia. This study aimed to investigate the hemodynamic stability, total amount of analgesic use, perioperative pain, stress response, postoperative complication and recovery in patients receiving TMP and ESP.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia
• Intervention / Treatment: Procedure: Transversus thoracic muscle plane block or Erector spinal plane block

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200120
      • Recruiting
      • Shanghai East Hospital of Tongji University
      • Contact: Le Yu, MM; Phone Number: 19921875120; Email: 907084943@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients (18-75 years) with BMI at 18-25 kg/m2, ASA Ⅱ- Ⅲ and NYHA Ⅱ-Ⅲ who scheduled to undergo mitral valve or aortic valve replacement surgery.

Exclusion Criteria:

• a second operation, preoperative ejection fraction (EF) < 40%, complicated coronary heart disease, intra-aortic balloon counterpulsation (IABP) support, psychiatric abnormalities, history of allergy to anesthetic drugs, liver or kidney dysfunction, coagulation abnormality, endocrine system diseases and metabolic diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transversus thoracic muscle plane block (T) group	Procedure: Transversus thoracic muscle plane block or Erector spinal plane block; Transversus thoracic muscle plane block or Erector spinal plane block
Experimental: Erector spinal plane block (E) group	Procedure: Transversus thoracic muscle plane block or Erector spinal plane block; Transversus thoracic muscle plane block or Erector spinal plane block
No Intervention: General anesthesia only (G) group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean arterial pressure	an average blood pressure in an individual during a single cardiac cycle	entering the operating room (T0)
Mean arterial pressure	an average blood pressure in an individual during a single cardiac cycle	intubation (T1)
Mean arterial pressure	an average blood pressure in an individual during a single cardiac cycle	skin incision (T2)
Mean arterial pressure	an average blood pressure in an individual during a single cardiac cycle	breast opening (T3)
Mean arterial pressure	an average blood pressure in an individual during a single cardiac cycle	sternal retractor placement (T4)
Mean arterial pressure	an average blood pressure in an individual during a single cardiac cycle	pericardium incision (T5)
Mean arterial pressure	an average blood pressure in an individual during a single cardiac cycle	steel wire pulling (T6)
Heart beats	the number of times each minute that heart beats	entering the operating room (T0)
Heart beats	the number of times each minute that heart beats	intubation (T1)
Heart beats	the number of times each minute that heart beats	skin incision (T2)
Heart beats	the number of times each minute that heart beats	breast opening (T3)
Heart beats	the number of times each minute that heart beats	sternal retractor placement (T4)
Heart beats	the number of times each minute that heart beats	pericardium incision (T5)
Heart beats	the number of times each minute that heart beats	steel wire pulling (T6)

Collaborators and Investigators

• Sponsor: Le Yu

Study record dates

Study Major Dates

• Study Start (Estimated): June 25, 2024
• Primary Completion (Estimated): August 25, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: June 16, 2024
• First Submitted That Met QC Criteria: June 16, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 16, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2024.6.25-2024.8.25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No