Coronary Artery Bypass Grafting or Heart Valve Surgery Via Median SternotomyNCT04838132
Transversus Thoracis Muscle Plane Block Plus Rectus Sheath Block in the Perioperative Pain Management of Cardiac Surgery
A study testing Bilateral transversus thoracis muscle plane and rectus sheath block with ropivacaine and Bilateral transversus thoracis muscle plane and rectus sheath puncture with saline in people with Coronary Artery Bypass Grafting or Heart Valve Surgery Via Median Sternotomy, run by Guangzhou First People's Hospital at 1 site in China.
Trial summary
An emerging regional block technique, transverse thoracic muscle block covers the T2-T6 intercostal nerves and can effectively relieve perioperative pain during median sternotomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Coronary Artery Bypass Grafting or Heart Valve Surgery Via Median Sternotomy
- What is being tested?
- Bilateral transversus thoracis muscle plane and rectus sheath block with ropivacaine and Bilateral transversus thoracis muscle plane and rectus sheath puncture with saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2021to 30 Nov 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients voluntarily cooperate with the study and sign an informed consent form;
- Ages between 18 and 65;
- American Society of Anesthesiologists (ASA) classification: I-III;
- Undergo coronary artery bypass grafting (CABG) or heart valve surgery with midsternal incision.
Who cannot join
- Refuse to participate in the trial;
- Allergic to the anesthetics or analgesics;
- Suffering with serious systemic diseases (kidney, liver, lungs and endocrine system);
- American Association of Anesthesiologists (ASA) classification: IV-V;
- Unstable hemodynamics;
- History of drug abuse or chronic pain;
- Mental disorders or communication difficulties;
- Died during or immediately after the operation.
Trial locations and contacts
1 site in 1 country.
Bin Zheng, doctor contact
China1 site, 1 recruiting
- Recruiting
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180
Jierong Luo, MD, 86-20-81048306, jierongluo@outlook.com
Jierong Luo, MD
About this study
Official title: Application of Transversus Thoracis Muscle Plane Block Plus Rectus Sheath Block in the Perioperative Pain Management of Cardiac Surgery : Study Protocol of a Randomized Double-blind Controlled Trial
An emerging regional block technique, transverse thoracic muscle block covers the T2-T6 intercostal nerves and can effectively relieve perioperative pain during median sternotomy. Bilateral transverse thoracic muscle plane( TTP) block is expected to be a new analgesic mode in perioperative of cardiac surgery via sternotomy.
Read the detailed description
This is a single-center, randomized, double-blind, parallel controlled clinical trial. Eighty patients planning to undergo coronary artery bypass grafting or heart valve surgery via median sternotomy were randomly assigned 1:1 to the experimental group or control group. After general anesthesia, all subjects were injected with 0.3% ropivacaine (experimental group) or 0.9% normal saline (control group) 15ml and 10ml respectively after insertion of a needle into bilateral transverse thoracic muscle plane and rectus sheath guided by B-ultrasound by anesthesiologist. The main outcome indicators were the threshold of incision pain and the total amount of analgesics used during the operation and 48h after the operation. Secondary outcome measures were as follows: postoperative VAS score, duration of mechanical ventilation, days in ICU, total days of hospitalization, and hospitalization cost. This study will provide evidence-based medical evidence and clinical data support for the application of TTP block in cardiac surgery.
- Being tested
- Bilateral transversus thoracis muscle plane and rectus sheath block with ropivacaine, Bilateral transversus thoracis muscle plane and rectus sheath puncture with saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral transversus thoracis muscle plane and rectus sheath block with ropivacaineProcedure or surgery
A linear array transducer (6-13 MHz) with a sterile cover and a 22-gauge (G) block needle (KDL™, Kindly group, Shanghai, China) will be used. Place the ultrasound probe on the longitudinal plane 1 cm outside the edge of the sternum in the fourth intercostal space, and identify the T3-T4 intercostal space under ultrasound. Use the plane technique to place a 22-gauge, 80-mm needle obliquely upwards until the needle tip is located at the plane between the internal intercostal muscles and the transverse pectoralis muscle. After general anesthesia, all subjects were injected with 0.3% ropivacaine 15ml and 10ml respectively after insertion of a needle into bilateral transverse thoracic muscle plane and rectus sheath guided by B-ultrasound.
Bilateral transversus thoracis muscle plane and rectus sheath puncture with salineProcedure or surgery
A linear array transducer (6-13 MHz) with a sterile cover and a 22-gauge (G) block needle (KDL™, Kindly group, Shanghai, China) will be used. Place the ultrasound probe on the longitudinal plane 1 cm outside the edge of the sternum in the fourth intercostal space, and identify the T3-T4 intercostal space under ultrasound. Use the plane technique to place a 22-gauge, 80-mm needle obliquely upwards until the needle tip is located at the plane between the internal intercostal muscles and the transverse pectoralis muscle. After general anesthesia, all subjects were injected with 0.9% saline 15ml and 10ml respectively after insertion of a needle into bilateral transverse thoracic muscle plane and rectus sheath guided by B-ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Transversus thoracis muscle plane and rectus sheath block with ropivacaine | Experimental | Using the plane technique to place a 22-gauge, 80-mm needle obliquely upwards until the needle tip is located at the plane between the internal intercostal muscles and the transverse pectoralis muscle (TTP block) and rectus sheath block, give 15ml and 10ml 0.3% ropivacaine respectively. Receives: Procedure: Bilateral transversus thoracis muscle plane and rectus sheath block with ropivacaine |
| Transversus thoracis muscle plane and rectus sheath puncture with saline | Experimental | Using the plane technique to place a 22-gauge, 80-mm needle obliquely upwards until the needle tip is located at the plane between the internal intercostal muscles and the transverse pectoralis muscle (TTP block) and rectus sheath block, give 15ml and 10ml 0.9% saline respectively. Receives: Procedure: Bilateral transversus thoracis muscle plane and rectus sheath puncture with saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hyperalgesia
a 180mN von-Frey wire (Touch Test™ Sensory Evaluator, USA) was used to test the pain sensitivity of the area around the wound
Measured: Surgery to 48 hours after
The total amount of analgesics used in the perioperative period.
During the perioperation, the amount of analgesics during the operation, the total amount of analgesic pump drugs used and the frequency of pressing the additional bolus trigger in the patient's analgesia system at 48 hours after the operation, and the amount of remedial analgesics
Measured: Surgery to 48 hours after
Secondary outcomes (4)
Visual Analogue Scale
A scale with a length of about 10cm is used. One side is marked with 10 scales, and the two ends are marked with "0" and "10" points respectively. 0 points mean painless, and 10 points mean the most intense pain that is unbearable
Measured: Extubation to 24 hours after
Length of stay in hospital
record how many days doses the patient spends in hospital
Measured: the day before hospital discharge
Postoperative complications
such as nausea and vomiting, pulmonary infection, wound infection, delayed healing, renal insufficiency, etc.
Measured: the day before hospital discharge
incidence of postoperative delirium
Changes in postoperative state of consciousness were assessed
Measured: Day 7 after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start16 Mar 2021
- Primary completion31 Oct 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass Grafting or Heart Valve Surgery Via Median SternotomyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou First People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bin Zheng, doctor, Study chair, Guangzhou First People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838132
- Sponsor's protocol ID
- K-2021-009-01
- Status last verified
- Mar 2021
- First submitted
- 30 Mar 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Transversus Thoracis Muscle Plane Block Plus Rectus Sheath Block in the Perioperative Pain Management of Cardiac Surgery : Study Protocol of a Randomized Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT04838132
- Acronym / sponsor ID
- K-2021-009-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Guangzhou First People's HospitalUniversity, hospital or other
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 8 Apr 2021 (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.
An emerging regional block technique, transverse thoracic muscle block covers the T2-T6 intercostal nerves and can effectively relieve perioperative pain during median sternotomy. Bilateral transverse thoracic muscle plane( TTP) block is expected to be a new analgesic mode in perioperative of cardiac surgery via sternotomy.
Detailed description
This is a single-center, randomized, double-blind, parallel controlled clinical trial. Eighty patients planning to undergo coronary artery bypass grafting or heart valve surgery via median sternotomy were randomly assigned 1:1 to the experimental group or control group. After general anesthesia, all subjects were injected with 0.3% ropivacaine (experimental group) or 0.9% normal saline (control group) 15ml and 10ml respectively after insertion of a needle into bilateral transverse thoracic muscle plane and rectus sheath guided by B-ultrasound by anesthesiologist. The main outcome indicators were the threshold of incision pain and the total amount of analgesics used during the operation and 48h after the operation. Secondary outcome measures were as follows: postoperative VAS score, duration of mechanical ventilation, days in ICU, total days of hospitalization, and hospitalization cost. This study will provide evidence-based medical evidence and clinical data support for the application of TTP block in cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transversus thoracis muscle plane and rectus sheath block with ropivacaine | Experimental | Procedure: Bilateral transversus thoracis muscle plane and rectus sheath block with ropivacaineUsing the plane technique to place a 22-gauge, 80-mm needle obliquely upwards until the needle tip is located at the plane between the internal intercostal muscles and the transverse pectoralis muscle (TTP block) and rectus sheath block, give 15ml and 10ml 0.3% ropivacaine respectively. |
| Transversus thoracis muscle plane and rectus sheath puncture with saline | Experimental | Procedure: Bilateral transversus thoracis muscle plane and rectus sheath puncture with salineUsing the plane technique to place a 22-gauge, 80-mm needle obliquely upwards until the needle tip is located at the plane between the internal intercostal muscles and the transverse pectoralis muscle (TTP block) and rectus sheath block, give 15ml and 10ml 0.9% saline respectively. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients voluntarily cooperate with the study and sign an informed consent form;
- Ages between 18 and 65;
- American Society of Anesthesiologists (ASA) classification: I-III;
- Undergo coronary artery bypass grafting (CABG) or heart valve surgery with midsternal incision.
Key exclusion criteria (8 listed)
- Refuse to participate in the trial;
- Allergic to the anesthetics or analgesics;
- Suffering with serious systemic diseases (kidney, liver, lungs and endocrine system);
- American Association of Anesthesiologists (ASA) classification: IV-V;
- Unstable hemodynamics;
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 |
|---|---|---|
| Bilateral transversus thoracis muscle plane and rectus sheath block with ropivacaineA linear array transducer (6-13 MHz) with a sterile cover and a 22-gauge (G) block needle (KDL™, Kindly group, Shanghai, China) will be used. Place the ultrasound probe on the longitudinal plane 1 cm outside the edge of the sternum in the fourth intercostal space, and identify the T3-T4 intercostal space under ultrasound. Use the plane technique to place a 22-gauge, 80-mm needle obliquely upwards until the needle tip is located at the plane between the internal intercostal muscles and the transverse pectoralis muscle. After general anesthesia, all subjects were injected with 0.3% ropivacaine 15ml and 10ml respectively after insertion of a needle into bilateral transverse thoracic muscle plane and rectus sheath guided by B-ultrasound. | Procedure or surgery | Transversus thoracis muscle plane and rectus sheath block with ropivacaine |
| Bilateral transversus thoracis muscle plane and rectus sheath puncture with salineA linear array transducer (6-13 MHz) with a sterile cover and a 22-gauge (G) block needle (KDL™, Kindly group, Shanghai, China) will be used. Place the ultrasound probe on the longitudinal plane 1 cm outside the edge of the sternum in the fourth intercostal space, and identify the T3-T4 intercostal space under ultrasound. Use the plane technique to place a 22-gauge, 80-mm needle obliquely upwards until the needle tip is located at the plane between the internal intercostal muscles and the transverse pectoralis muscle. After general anesthesia, all subjects were injected with 0.9% saline 15ml and 10ml respectively after insertion of a needle into bilateral transverse thoracic muscle plane and rectus sheath guided by B-ultrasound. | Procedure or surgery | Transversus thoracis muscle plane and rectus sheath puncture with saline |
Primary outcome
Incidence of hyperalgesia
Time frame: Surgery to 48 hours after
a 180mN von-Frey wire (Touch Test™ Sensory Evaluator, USA) was used to test the pain sensitivity of the area around the wound
The total amount of analgesics used in the perioperative period.
Time frame: Surgery to 48 hours after
During the perioperation, the amount of analgesics during the operation, the total amount of analgesic pump drugs used and the frequency of pressing the additional bolus trigger in the patient's analgesia system at 48 hours after the operation, and the amount of remedial analgesics
4 secondary outcomes
Visual Analogue Scale
Time frame: Extubation to 24 hours after
Length of stay in hospital
Time frame: the day before hospital discharge
Postoperative complications
Time frame: the day before hospital discharge
incidence of postoperative delirium
Time frame: Day 7 after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
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.
Bin Zheng, doctor contact
Bin Zheng, doctor study chair
Guangzhou First People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral transversus thoracis muscle plane and rectus sheath block with ropivacaine and Bilateral transversus thoracis muscle plane and rectus sheath puncture with saline in people with Coronary Artery Bypass Grafting or Heart Valve Surgery Via Median Sternotomy, run by Guangzhou First People's Hospital 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 4 inclusion and 8 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 8 Apr 2021. 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?
Contact Jierong Luo, master (+8615802031110, jierongluo@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hyperalgesia (time frame: Surgery to 48 hours after). The study lists 2 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 8 Apr 2021.