NCT07412522 Serratus Posterior Superior Intercostal Plane Block for Analgesia in Off-Pump Minimally Invasive CABG
| NCT ID | NCT07412522 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kartal Kosuyolu High Speciality Training and Research Hospital |
| Condition | Postoperative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-09-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Postoperative pain after cardiac surgery is commonly moderate to severe due to sternotomy, thoracotomy, internal mammary artery harvesting, and chest tube placement, and may contribute to adverse systemic and pulmonary outcomes if inadequately managed. Enhanced Recovery After Surgery (ERAS) protocols emphasize opioid-sparing strategies to reduce opioid-related side effects and complications. Ultrasound-guided fascial plane blocks have increasingly been incorporated into perioperative analgesia protocols for cardiac surgery. The serratus posterior superior intercostal plane block (SPSIPB), a recently described technique, provides wide dermatomal sensory coverage and may offer effective analgesia in thoracic and cardiac surgical procedures. This prospective, randomized controlled study aims to evaluate the analgesic efficacy of SPSIPB in adult patients undergoing off-pump minimally invasive coronary artery bypass grafting (CABG). A total of 60 ASA III patients aged 18 years or older will be randomized into two groups: SPSIPB group and control group. The SPSIPB will be performed preoperatively under ultrasound guidance using 0.25% bupivacaine, while the control group will receive standard general anesthesia without any plane block. All patients will receive standardized general anesthesia and postoperative patient-controlled analgesia with tramadol. The primary outcome of the study is postoperative recovery quality assessed using the Quality of Recovery-15 (QoR-15) questionnaire. Secondary outcomes include intraoperative remifentanil consumption, postoperative opioid requirements, time to first rescue analgesia, numerical rating scale (NRS) pain scores at rest and during coughing, extubation time, intensive care unit and hospital length of stay, and postoperative complications such as nausea, vomiting, and atelectasis. This study aims to determine whether SPSIPB can improve postoperative recovery quality and reduce opioid consumption in patients undergoing off-pump minimally invasive CABG.
Eligibility Criteria
Inclusion Criteria: * Patients aged 18-75 years * ASA physical status II-III * Scheduled for elective off-pump minimally invasive coronary artery bypass grafting (CABG) surgery * Ability to understand and use the Numerical Rating Scale (NRS) * Ability to provide written informed consent Exclusion Criteria: * Refusal to participate in the study * Known allergy or contraindication to local anesthetics * Coagulation disorders or ongoing anticoagulant therapy incompatible with regional anesthesia * Infection at the block injection site * Severe hepatic or renal dysfunction * Chronic opioid use or opioid dependence * History of chronic pain syndromes * Severe pulmonary disease (e.g., advanced COPD) * Neurological or psychiatric disorders that may interfere with pain assessment * Emergency surgery * Conversion to on-pump CABG or sternotomy during surgery
Contact & Investigator
Mustafa Burgaç, himself
PRINCIPAL INVESTIGATOR
mustafaburgac@outlook.com
Frequently Asked Questions
Who can join the NCT07412522 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Postoperative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07412522 currently recruiting?
Yes, NCT07412522 is actively recruiting participants. Contact the research team at mustafaburgac@gmail.com for enrollment information.
Where is the NCT07412522 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07412522 clinical trial?
NCT07412522 is sponsored by Kartal Kosuyolu High Speciality Training and Research Hospital. The principal investigator is Mustafa Burgaç, himself at mustafaburgac@outlook.com. The trial plans to enroll 60 participants.