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Clinical Trials/NCT06469073
NCT06469073RecruitingNot Applicable

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

Le Yu1 site in 1 country60 target enrollmentStarted: June 25, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Heart beats

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

General anesthesia only (G) group

No Intervention

Transversus thoracic muscle plane block (T) group

Experimental

Intervention: Transversus thoracic muscle plane block or Erector spinal plane block (Procedure)

Erector spinal plane block (E) group

Experimental

Intervention: Transversus thoracic muscle plane block or Erector spinal plane block (Procedure)

Outcomes

Primary Outcomes

Heart beats

Time Frame: steel wire pulling (T6)

the number of times each minute that heart beats

Mean arterial pressure

Time Frame: steel wire pulling (T6)

an average blood pressure in an individual during a single cardiac cycle

Mean arterial pressure

Time Frame: breast opening (T3)

an average blood pressure in an individual during a single cardiac cycle

Mean arterial pressure

Time Frame: entering the operating room (T0)

an average blood pressure in an individual during a single cardiac cycle

Mean arterial pressure

Time Frame: intubation (T1)

an average blood pressure in an individual during a single cardiac cycle

Mean arterial pressure

Time Frame: skin incision (T2)

an average blood pressure in an individual during a single cardiac cycle

Mean arterial pressure

Time Frame: sternal retractor placement (T4)

an average blood pressure in an individual during a single cardiac cycle

Mean arterial pressure

Time Frame: pericardium incision (T5)

an average blood pressure in an individual during a single cardiac cycle

Heart beats

Time Frame: entering the operating room (T0)

the number of times each minute that heart beats

Heart beats

Time Frame: intubation (T1)

the number of times each minute that heart beats

Heart beats

Time Frame: skin incision (T2)

the number of times each minute that heart beats

Heart beats

Time Frame: breast opening (T3)

the number of times each minute that heart beats

Heart beats

Time Frame: sternal retractor placement (T4)

the number of times each minute that heart beats

Heart beats

Time Frame: pericardium incision (T5)

the number of times each minute that heart beats

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Le Yu
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Le Yu

Clinicians

Shanghai East Hospital of Tongji University

Study Sites (1)

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