Ischemic Heart Disease (IHD)NCT07794527
Efficacy of Multiple Nerve Blocks on the Recovery of Patients Undergoing Off Pump CABG Surgeries
A study testing regional nerve block with local anesthesia in people with Ischemic Heart Disease (IHD) and Off-pump Coronary Artery Bypass, run by Ain Shams University at 1 site in Egypt.
Trial summary
In cardiac surgery patients , effective pain control is crucial to support early extubation, mobilization, and cognitive recovery, yet systemic opioids carry substantial risks such as respiratory depression, delirium, and delayed rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ischemic Heart Disease (IHD), Off-pump Coronary Artery Bypass, Regional Block for Pain Control
- What is being tested?
- regional nerve block with local anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2026to 7 Apr 2027
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- o Scheduled for elective off-pump coronary artery bypass graft (OPCAB) surgery via median sternotomy
- American Society of Anesthesiologists (ASA) physical status III - IV
- Ability to provide informed consent
Who cannot join
- o Emergency or redo cardiac surgery
- On-pump CABG or concomitant valve or aortic procedures
- Known allergy to local anesthetics or study drugs
- Coagulopathy or ongoing anticoagulant therapy contraindicating regional block
- Preoperative chronic opioid use or opioid dependency
- Neurologic or psychiatric conditions interfering with pain assessment
Show all 10Show fewer
- Infection at the block injection site
- Severe hepatic or renal impairment
- Body mass index (BMI) > 40 kg/m²
- Inability to understand or cooperate with pain scoring or postoperative care.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Enhancement of the Recovery Profile in Patients Undergoing Off-Pump Coronary Artery Bypass Graft Surgery Through Combination of Multiple Regional Nerve Blocks
In cardiac surgery patients , effective pain control is crucial to support early extubation, mobilization, and cognitive recovery, yet systemic opioids carry substantial risks such as respiratory depression, delirium, and delayed rehabilitation. While regional fascial plane blocks offer a safer, opioid-sparing alternative, no single technique provides complete analgesia for the complex and multi-dermatomal pain generated by sternotomy, graft harvesting, chest wall retraction, and drain sites. Therefore, a multimodal approach combining blocks such as parasternal nerve block , rectus sheath nerve block and femoral nerve block , may cover most of areas expected to be sources of intraoperative and post-operative pain in cardiac surgery patients.
- Conditions
- Ischemic Heart Disease (IHD), Off-pump Coronary Artery Bypass, Regional Block for Pain Control
- Being tested
- regional nerve block with local anesthesia, Placebo
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regional nerve block with local anesthesiaProcedure or surgery
Patients will receive bilateral superficial parasternal nerve block using 20 mL of 0.25% bupivacaine per side, in combination with a rectus sheath block (RSB) using 10 mL of 0.25% bupivacaine per side. and femoral nerve block at the side of harvesting using 10 mL of 0.25% bupivacaine.
PlaceboProcedure or surgery
Patients will receive placebo (saline) injections administered in the same anatomical planes.
| Study group | Role | What they receive |
|---|---|---|
| Group A (intervention) | Active comparator | Patients in this group will receive standardized general anaesthesia with a preemptive bilateral superficial parasternal nerve block using 20 mL of 0.25% bupivacaine per side, in combination with a rectus sheath block (RSB) using 10 mL of 0.25% bupivacaine per side. and femoral nerve block at the side of harvesting using 10 mL of 0.25% bupivacaine. Receives: Procedure: regional nerve block with local anesthesia |
| Group B ( control) | Placebo comparator | Patients will receive standardized general anesthesia with placebo (saline) injections administered in the same anatomical planes. Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Extubation
Defined as the interval (in hours) from transferal to ICU to successful tracheal extubation
Measured: from transferal to ICU until successful tracheal extubation assessed during post operative ICU stay up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start10 Sep 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion7 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart Disease (IHD)Studies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sherif S Sultan, MD, Study director, faculty of medicine Ain Shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794527
- Sponsor's protocol ID
- FMASU MD362/2025
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancement of the Recovery Profile in Patients Undergoing Off-Pump Coronary Artery Bypass Graft Surgery Through Combination of Multiple Regional Nerve Blocks
- ClinicalTrials.gov ID
- NCT07794527
- Acronym / sponsor ID
- FMASU MD362/2025
- Conditions
- Ischemic Heart Disease (IHD), Off-pump Coronary Artery Bypass, Regional Block for Pain Control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 7 Apr 2027 (estimated)
- First posted
- 31 Aug 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.
In cardiac surgery patients , effective pain control is crucial to support early extubation, mobilization, and cognitive recovery, yet systemic opioids carry substantial risks such as respiratory depression, delirium, and delayed rehabilitation. While regional fascial plane blocks offer a safer, opioid-sparing alternative, no single technique provides complete analgesia for the complex and multi-dermatomal pain generated by sternotomy, graft harvesting, chest wall retraction, and drain sites. Therefore, a multimodal approach combining blocks such as parasternal nerve block , rectus sheath nerve block and femoral nerve block , may cover most of areas expected to be sources of intraoperative and post-operative pain in cardiac surgery patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (intervention) | Active comparator | Procedure: regional nerve block with local anesthesiaPatients in this group will receive standardized general anaesthesia with a preemptive bilateral superficial parasternal nerve block using 20 mL of 0.25% bupivacaine per side, in combination with a rectus sheath block (RSB) using 10 mL of 0.25% bupivacaine per side. and femoral nerve block at the side of harvesting using 10 mL of 0.25% bupivacaine. |
| Group B ( control) | Placebo comparator | Procedure: PlaceboPatients will receive standardized general anesthesia with placebo (saline) injections administered in the same anatomical planes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- o Scheduled for elective off-pump coronary artery bypass graft (OPCAB) surgery via median sternotomy
Key exclusion criteria (10 listed)
- o Emergency or redo cardiac surgery
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 |
|---|---|---|
| regional nerve block with local anesthesiaPatients will receive bilateral superficial parasternal nerve block using 20 mL of 0.25% bupivacaine per side, in combination with a rectus sheath block (RSB) using 10 mL of 0.25% bupivacaine per side. and femoral nerve block at the side of harvesting using 10 mL of 0.25% bupivacaine. | Procedure or surgery | Group A (intervention) |
| PlaceboPatients will receive placebo (saline) injections administered in the same anatomical planes. | Procedure or surgery | Group B ( control) |
Primary outcome
Time to Extubation
Time frame: from transferal to ICU until successful tracheal extubation assessed during post operative ICU stay up to 48 hours
Defined as the interval (in hours) from transferal to ICU to successful tracheal extubation
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 31 Aug 2026.
- 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.
Sherif S Sultan, MD study director
faculty of medicine Ain Shams 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 regional nerve block with local anesthesia in people with Ischemic Heart Disease (IHD) and Off-pump Coronary Artery Bypass, 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 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 31 Aug 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 Abdelrahman H Ashour (+2-1010184467, AbdelrahmanAshour@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Extubation (time frame: from transferal to ICU until successful tracheal extubation assessed during post operative ICU stay up to 48 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 31 Aug 2026.