Acute Post Operative PainNCT05681507
Efficacy of TTMPB in Adult Cardiac Surgery
A study testing Transversus thoracic muscle plane block and Standard postoperative analgesia in people with Acute Post Operative Pain, run by Eric Albrecht at 1 site in Switzerland.
Trial summary
The goal of this clinical trial is to compare the efficacy of Transversus Thoracic Muscle Plane Block (TTMPB) integrated in a modern multimodal analgesia protocol, following the ERAS® recommendations, in adult patients undergoing planned open heart surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Post Operative Pain
- What is being tested?
- Transversus thoracic muscle plane block and Standard postoperative analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2022to 31 May 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Direct informed consent as documented by signature
- Major adult (≥ 18 years old) with body weight ≥ 50 kg. For the record, fifty kilograms is the minimal weight to ensure that participants remain safely away from maximal doses of LA (3 mg/kg)
- Planned and primary cardiac surgery via a sternotomy approach
- Planned for ultra-fast-track procedure (i.e. postoperative extubation time of maximum two hours)
Who cannot join
- Participation in another study with investigational drug within the 30 days preceding and during the present study
- Refusal and/or inability to understand or sign the informed consent
- Emergent cardiac surgery
- Previous cardiac surgery
- Known hypersensitivity or true allergy to bupivacaine and other amide-class LA
- Chronic pain history
Show all 10Show fewer
- Substance abuse history
- Inability to follow the procedures of the study (e.g. due to language problems, psychological / psychiatric disorders, dementia)
- Clinically significant concomitant diseases: severe cardiac dysfunction (i.e. LVEF ≤ 35%); severe chronic obstructive pulmonary disease (i.e. FEV < 50%); severe hepatic disease.
- Severe obesity (BMI > 35kg/m2)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
CHUVaudois
Lausanne, Canton of Vaud, 1011
Valentina Rancati, Attending Physician, 0041795568868, valentina.rancati@chuv.ch
About this study
Official title: Efficacy of Transversus Thoracic Muscle Plane Block in Adult Cardiac Surgery: A Randomized Controlled Trial
The goal of this clinical trial is to compare the efficacy of Transversus Thoracic Muscle Plane Block (TTMPB) integrated in a modern multimodal analgesia protocol, following the ERAS® recommendations, in adult patients undergoing planned open heart surgery.
The main study question is:
Read more
Does the addition of TTMPB to a standard analgesic protocol significantly improve analgesia following elective open heart surgery?
The investigators will primarily compare postoperative opioid consumption and pain scores in patients who will be randomly allocated to one of two groups:
The control group will receive standard analgesia per institutional Intensive Care Unit protocol.
The intervention group will receive the same standard of care plus a TTMP block (40ml of bupivacaine 0.375%, total dose of 150 mg).
The investigators will also study the impact of group allocation on secondary outcomes, such as the rate of early mobilization.
- Conditions
- Acute Post Operative Pain
- Being tested
- Transversus thoracic muscle plane block, Standard postoperative analgesia
- Keywords
- Transversus Thoracic Muscle Plane Block, Adult Cardiac Surgery, Sternotomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus thoracic muscle plane blockDrug
Also called TTMPB
Ultrasound guided bilateral parasternal injection of bupivacain 0.375%, 20ml, at 4th thoracic vertebral level.
Standard postoperative analgesiaProcedure or surgery
Standard of postoperative ICU analgesic care, per institutional protocol
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients will benefit of our institutional intensive-care unit analgesia protocol Receives: Procedure: Standard postoperative analgesia |
| Intervention group | Experimental | Patients will benefit of a transversus thoracic muscle plane block and our institutional intensive-care unit analgesia protocol Receives: Drug: Transversus thoracic muscle plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount (in mg) of opioid consumption within the first 24 hours
Total opioid consumption
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start1 Dec 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Post Operative PainStudies 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eric Albrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eric Albrecht, Centre Hospitalier Universitaire Vaudois
- Investigators
- Valentina Rancati, Attending physician, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681507
- Sponsor's protocol ID
- TTMPB-Heart Trial (2022-01126)
- Status last verified
- Jan 2023
- First submitted
- 13 Dec 2022
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transversus Thoracic Muscle Plane Block in Adult Cardiac Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05681507
- Acronym / sponsor ID
- TTMPB-Heart Trial (2022-01126)
- Conditions
- Acute Post Operative Pain
- Keywords
- Transversus Thoracic Muscle Plane Block, Adult Cardiac Surgery, Sternotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Eric AlbrechtUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 12 Jan 2023 (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.
The goal of this clinical trial is to compare the efficacy of Transversus Thoracic Muscle Plane Block (TTMPB) integrated in a modern multimodal analgesia protocol, following the ERAS® recommendations, in adult patients undergoing planned open heart surgery.
The main study question is:
Does the addition of TTMPB to a standard analgesic protocol significantly improve analgesia following elective open heart surgery?
The investigators will primarily compare postoperative opioid consumption and pain scores in patients who will be randomly allocated to one of two groups:
The control group will receive standard analgesia per institutional Intensive Care Unit protocol.
The intervention group will receive the same standard of care plus a TTMP block (40ml of bupivacaine 0.375%, total dose of 150 mg).
The investigators will also study the impact of group allocation on secondary outcomes, such as the rate of early mobilization.
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 |
|---|---|---|
| Control group | Active comparator | Procedure: Standard postoperative analgesiaPatients will benefit of our institutional intensive-care unit analgesia protocol |
| Intervention group | Experimental | Drug: Transversus thoracic muscle plane blockPatients will benefit of a transversus thoracic muscle plane block and our institutional intensive-care unit analgesia protocol |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Direct informed consent as documented by signature
- Major adult (≥ 18 years old) with body weight ≥ 50 kg. For the record, fifty kilograms is the minimal weight to ensure that participants remain safely away from maximal doses of LA (3 mg/kg)
- Planned and primary cardiac surgery via a sternotomy approach
- Planned for ultra-fast-track procedure (i.e. postoperative extubation time of maximum two hours)
Key exclusion criteria (10 listed)
- Participation in another study with investigational drug within the 30 days preceding and during the present study
- Refusal and/or inability to understand or sign the informed consent
- Emergent cardiac surgery
- Previous cardiac surgery
- Known hypersensitivity or true allergy to bupivacaine and other amide-class LA
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 blockAlso: TTMPBUltrasound guided bilateral parasternal injection of bupivacain 0.375%, 20ml, at 4th thoracic vertebral level. | Drug | Intervention group |
| Standard postoperative analgesiaStandard of postoperative ICU analgesic care, per institutional protocol | Procedure or surgery | Control group |
Primary outcome
Total amount (in mg) of opioid consumption within the first 24 hours
Time frame: 24 hours
Total opioid consumption
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
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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.
Valentina Rancati, Attending physician principal investigator
Centre Hospitalier Universitaire Vaudois
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 and Standard postoperative analgesia in people with Acute Post Operative Pain, run by Eric Albrecht at 1 site in Switzerland.
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 10 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 23 Jan 2023. 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 Switzerland. 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 Valentina Rancati, Attending physician (0041 79 556 88 68, valentina.rancati@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amount (in mg) of opioid consumption within the first 24 hours (time frame: 24 hours). 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 23 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.