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

NCT ID: NCT06469073

Last Updated: 2024-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-25

Study Completion Date

2024-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Transversus thoracic muscle plane block (T) group

Group Type EXPERIMENTAL

Transversus thoracic muscle plane block or Erector spinal plane block

Intervention Type PROCEDURE

Transversus thoracic muscle plane block or Erector spinal plane block

Erector spinal plane block (E) group

Group Type EXPERIMENTAL

Transversus thoracic muscle plane block or Erector spinal plane block

Intervention Type PROCEDURE

Transversus thoracic muscle plane block or Erector spinal plane block

General anesthesia only (G) group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Transversus thoracic muscle plane block or Erector spinal plane block

Transversus thoracic muscle plane block or Erector spinal plane block

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Le Yu

OTHER

Sponsor Role lead

Responsible Party

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Le Yu

Clinicians

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Shanghai East Hospital of Tongji University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Le Yu, MM

Role: primary

19921875120

Other Identifiers

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2024.6.25-2024.8.25

Identifier Type: -

Identifier Source: org_study_id

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