Transversus Thoracic Muscle Plane BlockNCT07417462
Assessment of a Multimodal Analgesia for Enhanced Recovery After Cardiac Surgery
A study testing Pecto-intercostal fascial block and Transversus thoracic muscle plane block in people with Transversus Thoracic Muscle Plane Block and Pecto-intercostal Fascial Block, run by Assiut University at 1 site in Egypt.
Trial summary
This work aims to assess the analgesic efficacies of transversus thoracic muscle plane block (TTPB) and transversus thoracic muscle plane block (TTPB) for open cardiac surgeries Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Transversus Thoracic Muscle Plane Block, Pecto-intercostal Fascial Block, Enhanced Recovery
- What is being tested?
- Pecto-intercostal fascial block and Transversus thoracic muscle plane block
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Feb 2026to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 40 to 60 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status II-III.
- Body mass index (BMI) < 35 kg/m2.
- Underwent cardiac surgery (coronary artery bypass graft surgery with median sternotomy).
Who cannot join
- Valve replacement procedures.
- Emergency operations.
- Redo surgeries.
- Minimally invasive approaches.
- The presence of psychiatric disorders.
- Cognitive impairment preventing accurate assessment using the verbal numerical rating scale (NRS).
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- Known hypersensitivity or a history of allergy to local anesthetics.
- Had severe major organ dysfunction.
- Left ventricular ejection fraction below 30%.
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, 71515
Noha H Abdelghany, MD, +966545945924, nohadaghash@gmail.com
Abdelrahman H Mohammed, MD
About this study
Official title: Assessment of a Multimodal Analgesia for Enhanced Recovery After Cardiac Surgery. A Prospective, Randomized, Study
This work aims to assess the analgesic efficacies of transversus thoracic muscle plane block (TTPB) and transversus thoracic muscle plane block (TTPB) for open cardiac surgeries
Read the detailed description
In patients undergoing open cardiac operation, pain management is crucial to the improved recovery. Postcardiac surgery pain is significant due to the sternotomy. The sternotomy is commonly cited as the most painful location following cardiac surgery, and postoperative pain is at its worst within the first 24 hours.
The transversus thoracic muscle plane block (TTPB) and the pectointercostal fascial block (PIFB) are new ultrasound (US)-guided regional anesthesia techniques planned to provide analgesia to the anterior thoracic wall. Both blocks primarily target the anterior cutaneous branches of the intercostal nerves (T2-T6), which are responsible for innervating the parasternal and medial anterior chest wall regions.
- Conditions
- Transversus Thoracic Muscle Plane Block, Pecto-intercostal Fascial Block, Enhanced Recovery, Cardiac Surgery
- Being tested
- Pecto-intercostal fascial block, Transversus thoracic muscle plane block, Sham (No Treatment)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pecto-intercostal fascial blockOther
Patients will receive pecto-intercostal fascial block intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg).
Transversus thoracic muscle plane blockOther
Patients will receive transversus thoracic muscle plane block was performed intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg).
Sham (No Treatment)Other
Patients will receive bilateral superficial needle puncture at a location like transversus thoracic muscle plane block without any solution injected. Only 25 saline will be injected superficially.
| Study group | Role | What they receive |
|---|---|---|
| Group PIFB | Experimental | Patients will receive pecto-intercostal fascial block intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg). Receives: Other: Pecto-intercostal fascial block |
| Group TTPB | Experimental | Patients will receive transversus thoracic muscle plane block was performed intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg). Receives: Other: Transversus thoracic muscle plane block |
| Control Group | Sham comparator | Patients will receive bilateral superficial needle puncture at a location like transversus thoracic muscle plane block without any solution injected. Only 25 saline will be injected superficially. Receives: Other: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount analgesic requirement
In cases where rescue analgesia is required [numerical rating scale (NRS) ≥4], intravenous Nalbuphine 0.1 mg/kg will be given.
Measured: 24 hours postoperatively
Secondary outcomes (8)
Degree of pain
Degree of pain will be assessed using Numerical rating scale (NRS) from 0 (no pain) to 10 (worst severe pain). NRS will be measured at 2h, 4h, 8h, 16h and 24h after surgery.
Measured: 24 hours postoperatively
The number of patients required rescue analgesia
The number of patients requires rescue analgesic will be recorded at 0, 3, 6, 12, 18, and 24 hours after extubation.
Measured: 24 hours postoperatively
Postoperative nausea and vomiting (PONV)
The patients will be verbally evaluated according to a descriptive five-point postoperative nausea and vomiting (PONV) scale at 0, 3, 6, 12, 18, and 24 hours after the extubation. If a score of 3 or more is registered, ondansetron 4 mg IV will be administered and repeated after 8 hours if required. The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once.
Measured: 24 hours postoperatively
Time to extubation
After the operation, the time until the patient is extubated will be recorded.
Measured: 24 hours postoperatively
Length of stay in the intensive care unit.
The time from admission to the intensive care unit (ICU) to the time of discharge to the hospital ward; during the hospital stay, an average of 7 days. Total duration of stay in ICU will be recorded.
Measured: Average 7 days postoperatively
Assessment of Delirium
Delirium will be assessed using the 3-minute diagnostic Confusion Assessment Method (CAM) (acute, inattention, disorganized thinking , altered of consciousness). The diagnosis of delirium by CAM requires presence of feature 1 \& 2 \& either 3 or 4. Delirium using the 3-minute diagnostic Confusion Assessment Method ( acute , inattention, disorganized thinking , altered of consciousness). The diagnosis of delirium by CAM requires presence of feature 1 \& 2 \& either 3 or 4. It will be evaluated 24 hrs after extubation.
Measured: 24 hours postoperatively
Level of patient satisfaction
Level of patient satisfaction estimated by a 5-point Likert scale (1:extremely dissatisfied; 2: unsatisfied; 3: neutral; 4: satisfied; 5: extremely satisfied).
Measured: 24 hours postoperatively
Incidence of complications.
Any complications-directly related to the block or the drug used in the block- will be recorded. Complications can include local anesthetic toxicity, vascular injury, pneumothorax, failed block, and anaphylactic shock.
Measured: 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start18 Feb 2026
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transversus Thoracic Muscle Plane BlockStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Hassan Abdel-Ghany, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417462
- Sponsor's protocol ID
- 04-2026-300788
- Status last verified
- Jul 2026
- First submitted
- 11 Feb 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Multimodal Analgesia for Enhanced Recovery After Cardiac Surgery. A Prospective, Randomized, Study
- ClinicalTrials.gov ID
- NCT07417462
- Acronym / sponsor ID
- 04-2026-300788
- Conditions
- Transversus Thoracic Muscle Plane Block, Pecto-intercostal Fascial Block, Enhanced Recovery, Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 18 Feb 2026 (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.
This work aims to assess the analgesic efficacies of transversus thoracic muscle plane block (TTPB) and transversus thoracic muscle plane block (TTPB) for open cardiac surgeries
Detailed description
In patients undergoing open cardiac operation, pain management is crucial to the improved recovery. Postcardiac surgery pain is significant due to the sternotomy. The sternotomy is commonly cited as the most painful location following cardiac surgery, and postoperative pain is at its worst within the first 24 hours.
The transversus thoracic muscle plane block (TTPB) and the pectointercostal fascial block (PIFB) are new ultrasound (US)-guided regional anesthesia techniques planned to provide analgesia to the anterior thoracic wall. Both blocks primarily target the anterior cutaneous branches of the intercostal nerves (T2-T6), which are responsible for innervating the parasternal and medial anterior chest wall regions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group PIFB | Experimental | Other: Pecto-intercostal fascial blockPatients will receive pecto-intercostal fascial block intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg). |
| Group TTPB | Experimental | Other: Transversus thoracic muscle plane blockPatients will receive transversus thoracic muscle plane block was performed intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg). |
| Control Group | Sham comparator | Other: Sham (No Treatment)Patients will receive bilateral superficial needle puncture at a location like transversus thoracic muscle plane block without any solution injected. Only 25 saline will be injected superficially. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age from 40 to 60 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status II-III.
- Body mass index (BMI) < 35 kg/m2.
- Underwent cardiac surgery (coronary artery bypass graft surgery with median sternotomy).
Key exclusion criteria (10 listed)
- Valve replacement procedures.
- Emergency operations.
- Redo surgeries.
- Minimally invasive approaches.
- The presence of psychiatric disorders.
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 |
|---|---|---|
| Pecto-intercostal fascial blockPatients will receive pecto-intercostal fascial block intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg). | Other | Group PIFB |
| Transversus thoracic muscle plane blockPatients will receive transversus thoracic muscle plane block was performed intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg). | Other | Group TTPB |
| Sham (No Treatment)Patients will receive bilateral superficial needle puncture at a location like transversus thoracic muscle plane block without any solution injected. Only 25 saline will be injected superficially. | Other | Control Group |
Primary outcome
Total amount analgesic requirement
Time frame: 24 hours postoperatively
In cases where rescue analgesia is required [numerical rating scale (NRS) ≥4], intravenous Nalbuphine 0.1 mg/kg will be given.
8 secondary outcomes
Degree of pain
Time frame: 24 hours postoperatively
The number of patients required rescue analgesia
Time frame: 24 hours postoperatively
Postoperative nausea and vomiting (PONV)
Time frame: 24 hours postoperatively
Time to extubation
Time frame: 24 hours postoperatively
Length of stay in the intensive care unit.
Time frame: Average 7 days postoperatively
Assessment of Delirium
Time frame: 24 hours postoperatively
Level of patient satisfaction
Time frame: 24 hours postoperatively
Incidence of complications.
Time frame: 7 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pecto-intercostal fascial block and Transversus thoracic muscle plane block in people with Transversus Thoracic Muscle Plane Block and Pecto-intercostal Fascial Block, run by Assiut University at 1 site in Egypt.
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 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: looking for participants now, as of the sponsor's last update on 21 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noha H Abdelghany, MD (+966545945924, nohadaghash@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amount analgesic requirement (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 21 Jul 2026.