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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06469073
• Other study ID #: 2024.6.25-2024.8.25
• Status: Recruiting
• Phase: N/A
• Start date: June 25, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: June 2024
• Source: Shanghai East Hospital of Tongji University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2024
• Est. primary completion date: August 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• patients (18-75 years) with BMI at 18-25 kg/m2, ASA ?- ? and NYHA ?-? 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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Procedure:
• Transversus thoracic muscle plane block or Erector spinal plane block
Transversus thoracic muscle plane block or Erector spinal plane block

Locations

Country	Name	City	State
China	Shanghai East Hospital of Tongji University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Le Yu

Country where clinical trial is conducted

China, 

Outcome

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