Postoperative PainPhase 4TTMP_BlockNCT06239025
Efficacy of Transversus Thoracis Muscle Plane Block in Patients Undergoing Cardiac Surgery
A Phase 4 study testing ultrasound-guided Transversus Thoracis Muscle Plane Block in people with Postoperative Pain, run by Hôpital du Valais at 1 site in Switzerland.
Trial summary
The goal of this randomized double blind study is to evaluate the analgesic efficacy of Transversus Thoracis Muscle Plane Block in patients undergoing cardiac surgery with median sternotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- ultrasound-guided Transversus Thoracis Muscle Plane Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Aug 2024to 12 Jun 2025
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Informed consent
- Major adult (≥ 18 years old)
- Body weight ≥ 50 kg. 50 kg is the minimal weight to ensure that participants will not receive an overdose of local anesthetic (ropivacaine 3 mg/kg)
- Primary cardiac surgery via a sternotomy approach
- Planned for fast-track procedure (i.e. postoperative extubation time of maximum six hours)
Who cannot join
- • Participation in another study within the 30 days preceding and during the present study
- Refusal and/or inability to understand or sign the informed consent
- Emergency cardiac surgery
- Previous cardiac surgery
- Hypersensitivity or allergy to ropivacaine and other amide-class LA
- History of chronic pain
Show all 9Show fewer
- History of substance abuse
- Severe cardiac dysfunction (i.e. LVEF ≤ 35%)
- Severe obesity (BMI > 40kg/m2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Transversus Thoracis Muscle Plane Block in Patients Undergoing Cardiac Surgery. A Randomized Controlled Trial
The goal of this randomized double blind study is to evaluate the analgesic efficacy of Transversus Thoracis Muscle Plane Block in patients undergoing cardiac surgery with median sternotomy.
one group of participants will receive multimodal analgesia plus ultrasound-guided Transversus Thoracis Muscle Plane Block with ropivacaine 0.5 % after induction of general anesthesia, the other group will receive multimodal analgesia without a bloc.
The investigators want to know if participants who receive the Transversus Thoracis Muscle Plane Block with ropivacaine have less pain than participants who do not receive a block.
Read the detailed description
Participants who undergo elective cardiac surgery with median sternotomy are eligible. They will receive general anaesthesia with multimodal analgesia as is standard in our institution. For study purposes participants will be randomized in a double blinded fashion to receive a Transversus Thoracis Muscle Plane Block with 30 mL of ropivacaine 0.5 %, or no block. As the block is carried out after induction of general anesthesia the participants will not know to which group they are assigned.
all blocks will be carried out after induction of general anesthesia, under full sterile precautions, and with ultrasound guidance. multimodal analgesia intra- and postoperatively is standardized and consists of: sufentanil, ketamine, dexmedetomidine, dexamethasone, paracetamol, metamizole, IV morphine in ICU.
The investigators aim for fast track surgery, i.e. extubation either in the operating room or in ICU within the first 6 postoperative hours.
the primary outcome is postoperative opioid consumption over the first 24 h postoperatively, secondary outcomes are pain scores and opioid-related side effects. all outcomes will be assessed by blinded investigators.
- Conditions
- Postoperative Pain
- Being tested
- ultrasound-guided Transversus Thoracis Muscle Plane Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided Transversus Thoracis Muscle Plane BlockOther
block with ropivacaine 0.5 %, 30 mL
| Study group | Role | What they receive |
|---|---|---|
| Block + multimodal analgesia | Active comparator | Multimodal analgesia + TTMP block with ropivacaine 0.5 %, 30 mL Receives: Other: ultrasound-guided Transversus Thoracis Muscle Plane Block |
| Multimodal Analgesia | No intervention | Multimodal Analgesia without a block |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioid consumption
cumulative intravenous morphine-equivalents
Measured: 24 hours postoperatively
Secondary outcomes (5)
Postoperative pain 2 h
Numeric Rating Scale 0-10
Measured: 2 hours postoperatively
Postoperative pain 6
Numeric Rating Scale 0-10
Measured: 6 hours postoperatively
Postoperative pain 12
Numeric Rating Scale 0-10
Measured: 12 hours postoperatively
Postoperative pain 24
Numeric Rating Scale 0-10
Measured: 24 hours postoperatively
ICU length of stay
ICU length of stay
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start15 Aug 2024
- Primary completion31 May 2025
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multimodal analgesia + ultrasound-guided Transversus Thoracis Muscle Plane Block with ropivacaine 0.5 % vs multimodal analgesia alone
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital du Valais
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239025
- Sponsor's protocol ID
- TTMP
- Acronym
- TTMP_Block
- Status last verified
- Jun 2025
- First submitted
- 25 Jan 2024
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transversus Thoracis Muscle Plane Block in Patients Undergoing Cardiac Surgery. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06239025
- Acronym / sponsor ID
- TTMP_Block / TTMP
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hôpital du ValaisUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 2 Feb 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.
The goal of this randomized double blind study is to evaluate the analgesic efficacy of Transversus Thoracis Muscle Plane Block in patients undergoing cardiac surgery with median sternotomy.
one group of participants will receive multimodal analgesia plus ultrasound-guided Transversus Thoracis Muscle Plane Block with ropivacaine 0.5 % after induction of general anesthesia, the other group will receive multimodal analgesia without a bloc.
The investigators want to know if participants who receive the Transversus Thoracis Muscle Plane Block with ropivacaine have less pain than participants who do not receive a block.
Detailed description
Participants who undergo elective cardiac surgery with median sternotomy are eligible. They will receive general anaesthesia with multimodal analgesia as is standard in our institution. For study purposes participants will be randomized in a double blinded fashion to receive a Transversus Thoracis Muscle Plane Block with 30 mL of ropivacaine 0.5 %, or no block. As the block is carried out after induction of general anesthesia the participants will not know to which group they are assigned.
all blocks will be carried out after induction of general anesthesia, under full sterile precautions, and with ultrasound guidance. multimodal analgesia intra- and postoperatively is standardized and consists of: sufentanil, ketamine, dexmedetomidine, dexamethasone, paracetamol, metamizole, IV morphine in ICU.
The investigators aim for fast track surgery, i.e. extubation either in the operating room or in ICU within the first 6 postoperative hours.
the primary outcome is postoperative opioid consumption over the first 24 h postoperatively, secondary outcomes are pain scores and opioid-related side effects. all outcomes will be assessed by blinded investigators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- multimodal analgesia + ultrasound-guided Transversus Thoracis Muscle Plane Block with ropivacaine 0.5 % vs multimodal analgesia alone
| Arm | Type | Receives |
|---|---|---|
| Block + multimodal analgesia | Active comparator | Other: ultrasound-guided Transversus Thoracis Muscle Plane BlockMultimodal analgesia + TTMP block with ropivacaine 0.5 %, 30 mL |
| Multimodal Analgesia | No intervention | –Multimodal Analgesia without a block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Informed consent
Key exclusion criteria (9 listed)
- • Participation in another study within the 30 days preceding and during the present study
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 |
|---|---|---|
| ultrasound-guided Transversus Thoracis Muscle Plane Blockblock with ropivacaine 0.5 %, 30 mL | Other | Block + multimodal analgesia |
Primary outcome
opioid consumption
Time frame: 24 hours postoperatively
cumulative intravenous morphine-equivalents
5 secondary outcomes
Postoperative pain 2 h
Time frame: 2 hours postoperatively
Postoperative pain 6
Time frame: 6 hours postoperatively
Postoperative pain 12
Time frame: 12 hours postoperatively
Postoperative pain 24
Time frame: 24 hours postoperatively
ICU length of stay
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ultrasound-guided Transversus Thoracis Muscle Plane Block in people with Postoperative Pain, run by Hôpital du Valais 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 15 Jun 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
opioid consumption (time frame: 24 hours postoperatively). 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 15 Jun 2025.