AnesthesiaNCT06469073
Ultrasound-guided Modified Transversus Thoracic Muscle Plane Block and Erector Spinal Muscle Plane Block in Heart Valve Replacement Surgery With Median Incision
A study testing Transversus thoracic muscle plane block or Erector spinal plane block in people with Anesthesia, run by Le Yu at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Transversus thoracic muscle plane block or Erector spinal plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2024to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital of Tongji University
Shanghai, Shanghai Municipality, 200120
Le Yu, MM, 19921875120, 907084943@qq.com
About this study
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.
- Conditions
- Anesthesia
- Being tested
- Transversus thoracic muscle plane block or Erector spinal plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus thoracic muscle plane block or Erector spinal plane blockProcedure or surgery
Transversus thoracic muscle plane block or Erector spinal plane block
| Study group | Role | What they receive |
|---|---|---|
| Transversus thoracic muscle plane block (T) group | Experimental | Not described Receives: Procedure: Transversus thoracic muscle plane block or Erector spinal plane block |
| Erector spinal plane block (E) group | Experimental | Not described Receives: Procedure: Transversus thoracic muscle plane block or Erector spinal plane block |
| General anesthesia only (G) group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial pressure
an average blood pressure in an individual during a single cardiac cycle
Measured: entering the operating room (T0)
Mean arterial pressure
an average blood pressure in an individual during a single cardiac cycle
Measured: intubation (T1)
Mean arterial pressure
an average blood pressure in an individual during a single cardiac cycle
Measured: skin incision (T2)
Mean arterial pressure
an average blood pressure in an individual during a single cardiac cycle
Measured: breast opening (T3)
Mean arterial pressure
an average blood pressure in an individual during a single cardiac cycle
Measured: sternal retractor placement (T4)
Mean arterial pressure
an average blood pressure in an individual during a single cardiac cycle
Measured: pericardium incision (T5)
Mean arterial pressure
an average blood pressure in an individual during a single cardiac cycle
Measured: steel wire pulling (T6)
Heart beats
the number of times each minute that heart beats
Measured: entering the operating room (T0)
Heart beats
the number of times each minute that heart beats
Measured: intubation (T1)
Heart beats
the number of times each minute that heart beats
Measured: skin incision (T2)
Heart beats
the number of times each minute that heart beats
Measured: breast opening (T3)
Heart beats
the number of times each minute that heart beats
Measured: sternal retractor placement (T4)
Heart beats
the number of times each minute that heart beats
Measured: pericardium incision (T5)
Heart beats
the number of times each minute that heart beats
Measured: steel wire pulling (T6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start25 Jun 2024 (estimated)
- Primary completion25 Aug 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Le Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Le Yu, Shanghai East Hospital of Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469073
- Sponsor's protocol ID
- 2024.6.25-2024.8.25
- Status last verified
- Jun 2024
- First submitted
- 16 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Modified Transversus Thoracic Muscle Plane Block and Erector Spinal Muscle Plane Block in Heart Valve Replacement Surgery With Median Incision
- ClinicalTrials.gov ID
- NCT06469073
- Acronym / sponsor ID
- 2024.6.25-2024.8.25
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Le YuUniversity, hospital or other
- Study start
- 25 Jun 2024 (estimated)
- Primary completion
- 25 Aug 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transversus thoracic muscle plane block or Erector spinal plane blockTransversus thoracic muscle plane block or Erector spinal plane block | Procedure or surgery | Erector spinal plane block (E) group, Transversus thoracic muscle plane block (T) group |
Primary outcome
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: breast opening (T3)
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
Mean arterial pressure
Time frame: steel wire pulling (T6)
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
Heart beats
Time frame: steel wire pulling (T6)
the number of times each minute that heart beats
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus thoracic muscle plane block or Erector spinal plane block in people with Anesthesia, run by Le Yu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean arterial pressure (time frame: entering the operating room (T0)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.