Transversus Thoracic Plane BlockNCT06546722
Transversus Thoracic Plane Block for Perioperative Analgesia in Cardiac Surgery
A study testing Transversus Thoracic Plane Block in people with Transversus Thoracic Plane Block and Cardiac Surgery, run by Saint-Joseph University at 1 site in Lebanon.
Trial summary
The goal of this clinical trial is to learn if perioperative Transversus Thoracic Plane Block (TTPB) decrease perioperative pain after cardiac surgery. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transversus Thoracic Plane Block, Cardiac Surgery, Post Operative Pain
- What is being tested?
- Transversus Thoracic Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Sep 2024to 20 Jul 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients scheduled for cardiac surgery via sternotomy under cardiopulmonary bypass
Who cannot join
- Previous cardiac surgery
- Urgent surgery
- Pregnant women
- Allergy to local anesthetics
- Opioid dependence
- Low ejection fraction < 30%
Show all 13Show fewer
- Presence or onset of cognitive or neurological disorders preventing pain assessment
- Infection at injection sites
- Coagulopathy
- Patients on dual antiplatelet therapy
- Renal insufficiency with Glomerular filtration rate (GFR) < 30 mL/min
- History of thoracic radiotherapy
- History of mastectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transversus Thoracic Plane Block for Perioperative Analgesia in Cardiac Surgery: a Randomized Controlled Prospective Study
The goal of this clinical trial is to learn if perioperative Transversus Thoracic Plane Block (TTPB) decrease perioperative pain after cardiac surgery. The main questions it aims to answer are:
- does Transversus Thoracic Plane Block decrease perioperative pain after cardiac surgery more than the standard analgesic treatment?
- Are the results different if the investigators perform Transversus Thoracic Plane Block before surgery or at the end of surgery?
- Being tested
- Transversus Thoracic 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.
Transversus Thoracic Plane BlockProcedure or surgery
The Transversus Thoracic Plane Block is a recent regional anesthesia technique. It provides analgesia for the anterior cutaneous branches of the intercostal nerves T2-6 to the medial anterior chest wall via a single injection of local anesthesia between the internal intercostal muscle and the transversus thoracic muscle located between the third and fourth (or fourth and fifth) intercostal space. It is noteworthy that the TTPB can consequently reduce pulmonary morbidity and the need for high-dose opioids.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | No intervention | This group receives standard analgesic treatment and no Transversus Thoracic Plane Block is performed |
| Transversus Thoracic Plane Block pre | Active comparator | This group receives standard analgesic treatment and Transversus Thoracic Plane Block is performed before surgery Receives: Procedure: Transversus Thoracic Plane Block |
| Transversus Thoracic Plane Block post | Active comparator | This group receives standard analgesic treatment and Transversus Thoracic Plane Block is performed at the end of surgery Receives: Procedure: Transversus Thoracic Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain score
The primary outcome is Postoperative Pain Score:
Numeric rating scale (NRS) ratings will be assessed at T1 (= upon patient awakening), T2 (= 12 hours postoperatively), T3 (= 24 hours postoperatively) as well as during various painful moments (coughing, drain removal, mobilization).
Numeric rating scale (NRS) is a unidimensional measure of pain intensity. It consists of the patient evaluating his pain out of a series of numbers ranging from 0 to 10, where the 2 respective endpoints are "0 = no pain" and "10 = worst possible pain."
Measured: First 24h postoperatively
Secondary outcomes (6)
Perioperative opioid requirement
Total dose of opioids required during surgery and 24h postoperatively
Measured: First 24h postoperatively
Time to first opioid administration
Time to first opioid administration after surgery
Measured: First 24h postoperatively
Time to extubation
Time between arrival to cardiac intensive care unit and extubation
Measured: First 24h postoperatively
Patient satisfaction at 24 hours post surgery
Patient satisfaction is measured by asking patients one question at 24 hours post surgery:
"On a scale from 0 to 10, 0 = not satisfied at all, 10 = extremely satisfied, how satisfied do you feel concerning pain management during the first 24 hours after surgery? "
Measured: First 24h postoperatively
Length of stay at cardiac intensive care unit and hospital stay
Length of stay at cardiac intensive care unit and hospital stay
Measured: 3 months postoperatively
Incidence of postoperative pneumonia and pneumothorax in cardiac intensive care unit
Incidence of postoperative pneumonia and pneumothorax in cardiac intensive care unit
Measured: First 24h postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Sep 2024
- Primary completion1 Jul 2025
- Study completion20 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Transversus Thoracic Plane BlockStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanna Tohme, Saint-Joseph University
- Investigators
- Samia Madi Jebara, MD,PHD, Study director, Saint-Joseph University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546722
- Sponsor's protocol ID
- CEHDF2392
- Status last verified
- Jul 2026
- First submitted
- 4 Aug 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jeanneteau A, Demarquette A, Blanchard-Daguet A, Fouquet O, Lasocki S, Riou J, Rineau E, Leger M. Effect of superficial and deep parasternal blocks on recovery after cardiac surgery: study protocol for a randomized controlled trial. Trials. 2023 Jul 6;24(1):444. doi: 10.1186/s13063-023-07446-2.
PubMed 37415221Wong HMK, Chen PY, Tang GCC, Chiu SLC, Mok LYH, Au SSW, Wong RHL. Deep Parasternal Intercostal Plane Block for Intraoperative Pain Control in Cardiac Surgical Patients for Sternotomy: A Prospective Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2024 Mar;38(3):683-690. doi: 10.1053/j.jvca.2023.11.038. Epub 2023 Nov 30.
PubMed 38148266Fujii S, Bairagi R, Roche M, Zhou JR. Transversus Thoracis Muscle Plane Block. Biomed Res Int. 2019 Jul 7;2019:1716365. doi: 10.1155/2019/1716365. eCollection 2019.
PubMed 31360703
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Thoracic Plane Block for Perioperative Analgesia in Cardiac Surgery: a Randomized Controlled Prospective Study
- ClinicalTrials.gov ID
- NCT06546722
- Acronym / sponsor ID
- CEHDF2392
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 9 Aug 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 clinical trial is to learn if perioperative Transversus Thoracic Plane Block (TTPB) decrease perioperative pain after cardiac surgery. The main questions it aims to answer are:
- does Transversus Thoracic Plane Block decrease perioperative pain after cardiac surgery more than the standard analgesic treatment?
- Are the results different if the investigators perform Transversus Thoracic Plane Block before surgery or at the end of surgery?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | No intervention | –This group receives standard analgesic treatment and no Transversus Thoracic Plane Block is performed |
| Transversus Thoracic Plane Block pre | Active comparator | Procedure: Transversus Thoracic Plane BlockThis group receives standard analgesic treatment and Transversus Thoracic Plane Block is performed before surgery |
| Transversus Thoracic Plane Block post | Active comparator | Procedure: Transversus Thoracic Plane BlockThis group receives standard analgesic treatment and Transversus Thoracic Plane Block is performed at the end of surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients scheduled for cardiac surgery via sternotomy under cardiopulmonary bypass
Key exclusion criteria (13 listed)
- Previous cardiac surgery
- Urgent surgery
- Pregnant women
- Allergy to local anesthetics
- Opioid dependence
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 Plane BlockThe Transversus Thoracic Plane Block is a recent regional anesthesia technique. It provides analgesia for the anterior cutaneous branches of the intercostal nerves T2-6 to the medial anterior chest wall via a single injection of local anesthesia between the internal intercostal muscle and the transversus thoracic muscle located between the third and fourth (or fourth and fifth) intercostal space. It is noteworthy that the TTPB can consequently reduce pulmonary morbidity and the need for high-dose opioids. | Procedure or surgery | Transversus Thoracic Plane Block post, Transversus Thoracic Plane Block pre |
Primary outcome
postoperative pain score
Time frame: First 24h postoperatively
The primary outcome is Postoperative Pain Score: Numeric rating scale (NRS) ratings will be assessed at T1 (= upon patient awakening), T2 (= 12 hours postoperatively), T3 (= 24 hours postoperatively) as well as during various painful moments (coughing, drain removal, mobilization). Numeric rating scale (NRS) is a unidimensional measure of pain intensity. It consists of the patient evaluating his pain out of a series of numbers ranging from 0 to 10, where the 2 respective endpoints are "0 = no pain" and "10 = worst possible pain."
6 secondary outcomes
Perioperative opioid requirement
Time frame: First 24h postoperatively
Time to first opioid administration
Time frame: First 24h postoperatively
Time to extubation
Time frame: First 24h postoperatively
Patient satisfaction at 24 hours post surgery
Time frame: First 24h postoperatively
Length of stay at cardiac intensive care unit and hospital stay
Time frame: 3 months postoperatively
Incidence of postoperative pneumonia and pneumothorax in cardiac intensive care unit
Time frame: First 24h postoperatively
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 14 Jul 2026.
- Background: PubMed 37415221Jeanneteau A, Demarquette A, Blanchard-Daguet A, Fouquet O, Lasocki S, Riou J, Rineau E, Leger M. Effect of superficial and deep parasternal blocks on recovery after cardiac surgery: study protocol for a randomized controlled trial. Trials. 2023 Jul 6;24(1):444. doi: 10.1186/s13063-023-07446-2.
- Background: PubMed 38148266Wong HMK, Chen PY, Tang GCC, Chiu SLC, Mok LYH, Au SSW, Wong RHL. Deep Parasternal Intercostal Plane Block for Intraoperative Pain Control in Cardiac Surgical Patients for Sternotomy: A Prospective Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2024 Mar;38(3):683-690. doi: 10.1053/j.jvca.2023.11.038. Epub 2023 Nov 30.
- Background: PubMed 31360703Fujii S, Bairagi R, Roche M, Zhou JR. Transversus Thoracis Muscle Plane Block. Biomed Res Int. 2019 Jul 7;2019:1716365. doi: 10.1155/2019/1716365. eCollection 2019.
- Individual participant dataSharing planned: No
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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.
Samia Madi Jebara, MD,PHD study director
Saint-Joseph University
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 Plane Block in people with Transversus Thoracic Plane Block and Cardiac Surgery, run by Saint-Joseph University at 1 site in Lebanon.
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 13 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 14 Jul 2026. 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 Lebanon. 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?
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?
postoperative pain score (time frame: First 24h postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06546722, which also lists 3 linked publications.
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 14 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.