Enhancement of the Recovery Profile in Patients Undergoing Off-Pump Coronary Artery Bypass Graft Surgery Through Combination of Multiple Regional Nerve Blocks
| Registry | NCT07794527 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: quadruple, prevention |
| Enrollment | 30 (Estimated) |
| Sponsor | Ain Shams University (Other) |
| Conditions | Ischemic Heart Disease (IHD), Off-pump Coronary Artery Bypass, Regional Block for Pain Control |
| Interventions | regional nerve block with local anesthesia, Placebo (Procedure) |
| Dates | start 2026-09-10 (estimated), primary completion 2027-03-31 (estimated), completion 2027-04-07 (estimated), first posted 2026-08-31, last updated 2026-08-31 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Ischemic Heart Disease (IHD) All trials for Off-pump Coronary Artery Bypass All trials of regional nerve block with local anesthesia All trials of Placebo
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group A (intervention) | Active comparator | Procedure: regional nerve block with local anesthesia | 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. |
| Group B ( control) | Placebo comparator | Procedure: Placebo | Patients will receive standardized general anesthesia with placebo (saline) injections administered in the same anatomical planes. |
Sex: All, ages: 18 Years to 65 Years
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Ain shams university hospitals | Cairo | Egypt | Recruiting |