Clinical trial NCT06469073: Ultrasound-guided Modified Transversus Thoracic Muscle Plane Block and Erector Spinal Muscle Plane Block in Heart Valve Replacement Surgery With Median Incision
Official title: Ultrasound-guided Modified Transversus Thoracic Muscle Plane Block and Erector Spinal Muscle Plane Block in Heart Valve Replacement Surgery With Median Incision
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anesthesia
Lead sponsor: Shanghai East Hospital of Tongji University
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean arterial pressure
timeFrame: entering the operating room (T0)
measure: Mean arterial pressure
timeFrame: intubation (T1)
measure: Mean arterial pressure
timeFrame: skin incision (T2)
measure: Mean arterial pressure
timeFrame: breast opening (T3)
measure: Mean arterial pressure
timeFrame: sternal retractor placement (T4)
measure: Mean arterial pressure
timeFrame: pericardium incision (T5)
measure: Mean arterial pressure
timeFrame: steel wire pulling (T6)
measure: Heart beats
timeFrame: entering the operating room (T0)
measure: Heart beats
timeFrame: intubation (T1)
measure: Heart beats
timeFrame: skin incision (T2)
measure: Heart beats
timeFrame: breast opening (T3)
measure: Heart beats
timeFrame: sternal retractor placement (T4)
measure: Heart beats
timeFrame: pericardium incision (T5)
measure: Heart beats
timeFrame: steel wire pulling (T6)
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital of Tongji University
state: Shanghai
Study officials:
References: