NCT06469073

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 21, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

June 25, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

June 16, 2024

Last Update Submit

June 16, 2024

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (14)

  • 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)

Study Arms (3)

Transversus thoracic muscle plane block (T) group

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

Erector spinal plane block (E) group

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

General anesthesia only (G) group

NO INTERVENTION

Interventions

Transversus thoracic muscle plane block or Erector spinal plane blockPROCEDURE

Transversus thoracic muscle plane block or Erector spinal plane block

Erector spinal plane block (E) groupTransversus thoracic muscle plane block (T) group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai East Hospital of Tongji University

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinicians

Study Record Dates

First Submitted

June 16, 2024

First Posted

June 21, 2024

Study Start

June 25, 2024

Primary Completion

August 25, 2024

Study Completion

September 1, 2024

Last Updated

June 21, 2024

Record last verified: 2024-06

Locations

CN(1)