Pain ManagementPhase 3IMA CABG PIPBNCT07663435
Influence of Superficial Parasternal Intercostal Plane Block on Internal Thoracic Artery Caliber to Facilitate Surgical Harvesting in CABG
A Phase 3 study testing Bupivacaine in people with Pain Management and Parasternal Block, run by Ain Shams University at 1 site in Egypt.
Trial summary
Influence of Superficial Parasternal Intercostal Plane Block (SPIPB) on Internal Thoracic Artery (ITA) Caliber and Surgical Harvesting Efficiency in Coronary Artery Bypass Grafting (CABG) Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Pain Management, Parasternal Block, CABG Graft Integrity
- What is being tested?
- Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 31 Dec 2026
- Phase
- Phase 3
- 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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Age group: Adult patients from age of 22 to 65 years.
- Sex: Both sexes
- Patients undergoing CABG with IMA harvesting
Who cannot join
- • Patients with pre-existing active bloodstream infection or systemic infection
- Refuse consent
- IMA graft not suitable
- Morbidly obese (BMI > 40 )
- Hemodynamic instability
- Severe pulmonary disease
Show all 9Show fewer
- Previous thoracic surgeries (makes it difficult to harvest IMA)
- Advanced malignancy or chronic disease with life expectancy less than six months
- Emergency surgery
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
Faculty of Medicine ,Ain Shams University
Cairo, Cairo Governorate
Sarah Hamdy,MD, lecturer of Anaesthesia, +201012434690, sarahhamdy@med.asu.edu.eg
About this study
Influence of Superficial Parasternal Intercostal Plane Block (SPIPB) on Internal Thoracic Artery (ITA) Caliber and Surgical Harvesting Efficiency in Coronary Artery Bypass Grafting (CABG)
Read the detailed description
Parasternal intercostal blocks (PSB) represent a newer approach to post-sternotomy pain management. Studies suggest their effectiveness in providing postoperative analgesia , with a significant advantage being their suitability even during concurrent antiplatelet or anticoagulant therapy.In addition to its sympatholytic effects cause vasodilatation , a reduction in vascular resistance, and an increase in local blood flow . The effects are maintained up to the early postoperative period .
- Conditions
- Pain Management, Parasternal Block, CABG Graft Integrity
- Being tested
- Bupivacaine
- Keywords
- IMA, CABG, SPIPB
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Superficial parasternal block will be given to assess diameter of IMA by using US to assess caliber and ease of harvesting.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine group | Active comparator | 10 ml of bupivacaine solution will be administered. Dose: 10 ml bupivacaine concentration 0.5% (each 1 ml contains 5 mg; total volume 10 ml equivalent to total 50 mg) will be given. Receives: Drug: Bupivacaine |
| Control group | No intervention | No intervention will be administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Internal Thoracic Artery (ITA) Diameter
Change in the diameter of the Internal Thoracic Artery (ITA) measured in millimeters (mm) after SPIPB administration.
Measured: Measured 15 minutes after the SPIPB injection by intraoperative ultrasound.
Change in Internal Thoracic Artery (ITA) Cross-Sectional Area
Change in the cross-sectional area of the Internal Thoracic Artery (ITA) measured in square millimeters (mm²) after SPIPB administration.
Measured: Measured 15 minutes after the SPIPB injection by Intraoperative ultrasound.
Secondary outcomes (5)
Time Required for ITA Harvesting
Total time in minutes (min) required to harvest the Internal Thoracic Artery.
Measured: Measured during the surgical harvesting procedure.
Technical Difficulty of ITA Harvesting
Assessed using a Technical Difficulty Scale. The scale ranges from 1 (Very Easy) to 5 (Very Difficult), where a higher score indicates a worse outcome (more difficult harvesting).
Measured: Assessed by the surgeon immediately after the harvesting procedure.
Postoperative Pain Score
Postoperative pain assessed using the Visual Analog Scale (VAS) for pain. The scale ranges from 0 mm (No Pain) to 100 mm (Worst Possible Pain), where a higher score indicates a worse outcome.
Measured: Measured at 24 hours postoperatively.
Postoperative Opioid Consumption
Total postoperative opioid consumption, measured in Morphine Milligram Equivalents (MME).
Measured: Measured over the first 24 hours postoperatively.
Intraoperative Hemodynamic Stability
Incidence of significant hemodynamic instability (e.g., episodes of hypotension or hypertension requiring intervention).
Measured: Measured during the intraoperative period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start1 Jul 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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 Pain ManagementStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Receive parasternal block
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sarah hamdy, Ain Shams University
- Investigators
- Sarah H Elghareeb, MD, Principal investigator, Ain Shams
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663435
- Sponsor's protocol ID
- 00006379
- Acronym
- IMA CABG PIPB
- Status last verified
- Oct 2026
- First submitted
- 14 Jun 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bupivacaine Dosage Guide + max dose, adjustments. Drugs.com. Accessed April 18, 2026. https://www.drugs.com/dosage/bupivacaine.html#Usual_Adult_Dose_for_Local_Anesthesia.
Walker JW, Cios TJ. Local Anesthetic Choice for Regional Techniques in Cardiac Surgery: The Sauce Matters. J Cardiothorac Vasc Anesth. 2025 Jan;39(1):8-12. doi: 10.1053/j.jvca.2024.10.029. Epub 2024 Oct 18. No abstract available.
PubMed 39505578Toscano A, Capuano P, Perrucci C, Giunta M, Orsello A, Pierani T, Costamagna A, Tedesco M, Arcadipane A, Sepolvere G, Buono G, Brazzi L. Which ultrasound-guided parasternal intercostal nerve block for post-sternotomy pain? Results from a prospective observational study. J Anesth Analg Crit Care. 2023 Nov 16;3(1):48. doi: 10.1186/s44158-023-00134-2.
PubMed 37974241
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Superficial Parasternal Intercostal Plane Block on Internal Thoracic Artery Caliber to Facilitate Surgical Harvesting in CABG
- ClinicalTrials.gov ID
- NCT07663435
- Acronym / sponsor ID
- IMA CABG PIPB / 00006379
- Conditions
- Pain Management, Parasternal Block, CABG Graft Integrity
- Keywords
- IMA, CABG, SPIPB
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Jun 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.
Influence of Superficial Parasternal Intercostal Plane Block (SPIPB) on Internal Thoracic Artery (ITA) Caliber and Surgical Harvesting Efficiency in Coronary Artery Bypass Grafting (CABG)
Detailed description
Parasternal intercostal blocks (PSB) represent a newer approach to post-sternotomy pain management. Studies suggest their effectiveness in providing postoperative analgesia , with a significant advantage being their suitability even during concurrent antiplatelet or anticoagulant therapy.In addition to its sympatholytic effects cause vasodilatation , a reduction in vascular resistance, and an increase in local blood flow . The effects are maintained up to the early postoperative period .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Receive parasternal block
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine group | Active comparator | Drug: Bupivacaine10 ml of bupivacaine solution will be administered. Dose: 10 ml bupivacaine concentration 0.5% (each 1 ml contains 5 mg; total volume 10 ml equivalent to total 50 mg) will be given. |
| Control group | No intervention | –No intervention will be administered |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Age group: Adult patients from age of 22 to 65 years.
Key exclusion criteria (9 listed)
- • Patients with pre-existing active bloodstream infection or systemic infection
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 |
|---|---|---|
| BupivacaineSuperficial parasternal block will be given to assess diameter of IMA by using US to assess caliber and ease of harvesting. | Drug | Bupivacaine group |
Primary outcome
Change in Internal Thoracic Artery (ITA) Diameter
Time frame: Measured 15 minutes after the SPIPB injection by intraoperative ultrasound.
Change in the diameter of the Internal Thoracic Artery (ITA) measured in millimeters (mm) after SPIPB administration.
Change in Internal Thoracic Artery (ITA) Cross-Sectional Area
Time frame: Measured 15 minutes after the SPIPB injection by Intraoperative ultrasound.
Change in the cross-sectional area of the Internal Thoracic Artery (ITA) measured in square millimeters (mm²) after SPIPB administration.
5 secondary outcomes
Time Required for ITA Harvesting
Time frame: Measured during the surgical harvesting procedure.
Technical Difficulty of ITA Harvesting
Time frame: Assessed by the surgeon immediately after the harvesting procedure.
Postoperative Pain Score
Time frame: Measured at 24 hours postoperatively.
Postoperative Opioid Consumption
Time frame: Measured over the first 24 hours postoperatively.
Intraoperative Hemodynamic Stability
Time frame: Measured during the intraoperative period.
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 28 Oct 2026.
- BackgroundBupivacaine Dosage Guide + max dose, adjustments. Drugs.com. Accessed April 18, 2026. https://www.drugs.com/dosage/bupivacaine.html#Usual_Adult_Dose_for_Local_Anesthesia.
- Background: PubMed 39505578Walker JW, Cios TJ. Local Anesthetic Choice for Regional Techniques in Cardiac Surgery: The Sauce Matters. J Cardiothorac Vasc Anesth. 2025 Jan;39(1):8-12. doi: 10.1053/j.jvca.2024.10.029. Epub 2024 Oct 18. No abstract available.
- Background: PubMed 37974241Toscano A, Capuano P, Perrucci C, Giunta M, Orsello A, Pierani T, Costamagna A, Tedesco M, Arcadipane A, Sepolvere G, Buono G, Brazzi L. Which ultrasound-guided parasternal intercostal nerve block for post-sternotomy pain? Results from a prospective observational study. J Anesth Analg Crit Care. 2023 Nov 16;3(1):48. doi: 10.1186/s44158-023-00134-2.
- Individual participant dataSharing planned: Undecided
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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.
Sarah H Elghareeb, MD principal investigator
Ain Shams
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupivacaine in people with Pain Management and Parasternal Block, run by Ain Shams 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 3 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: looking for participants now, as of the sponsor's last update on 28 Oct 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sarah hamdy Elghareeb, MD (+201012434690, sarahhamdy@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Internal Thoracic Artery (ITA) Diameter (time frame: Measured 15 minutes after the SPIPB injection by intraoperative ultrasound.). 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?
On the ClinicalTrials.gov record for NCT07663435, 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 28 Oct 2026.