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Clinical Trials in Turkey / NCT07412522
Recruiting Not applicable

Serratus Posterior Superior Intercostal Plane Block for Analgesia in Off-Pump Minimally Invasive CABG

NCT07412522 · tracked via the Priya Life Science Turkey tracker
Sponsor
Kartal Kosuyolu High Speciality Training and Research Hospital
Phase
Not applicable
Started
2025-09-01
Last updated
2026-02-17

Condition(s) studied

Postoperative PainPostoperative Analgesia

Investigational drug(s) / intervention(s)

Serratus Posterior Superior Intercostal Plane Block (SPSIPB)Bupivacaine →Ultrasound

Serratus Posterior Superior Intercostal Plane Block (SPSIPB): Ultrasound-guided serratus posterior superior intercostal plane block (SPSIPB) will be performed prior to induction of general anesthesia under sterile conditions. Patients will be positioned laterally with the surgical side up. Using a high-frequency linear ultrasound probe, the scapular spine and the third rib will be identified medial to the scapula. After confirmation of the serratus posterior superior muscle and pleura, the needle will be advanced until contact with the third rib is achieved. Following hydrodissection with 5 mL of isotonic saline, 30 mL of 0.25% bupivacaine (1 mg/kg) will be injected between the serratus posterior superior muscle and the third rib. Cranio-caudal spread of the local anesthetic will be confirmed under ultrasound guidance. All participants will subsequently receive standardized general anesthesia and postoperative analgesia according to the institutional protocol.

Bupivacaine: Bupivacaine was administered as the local anesthetic for the block.

Ultrasound: Ultrasound guidance was used for block placement.

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Kosuyolu High Specialization Training and Research Hospital Istanbul Turkey (Türkiye) Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07412522 on ClinicalTrials.gov ↗ ← All trials in Turkey