NCT06418100

Recto-intercostal Block for Coronary Artery Bypass Grafting

Recto-intercostal Fascial Plane Block for Postoperative Analgesia in Coronary Artery Bypass Grafting With Sternotomy: a Randomized, Double-blind, Controlled Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Haseki Training and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This interventional study aims to learn about the postoperative analgesic efficacy of a new fascial plane block, recto-intercostal fascial plane block, at coronary artery bypass grafting with sternotomy. There will be two groups, one of which will be the control group, and the other will be the study group randomly receiving postoperative recto-intercostal fascial plane block. The main questions it aims to answer are the effect of this new block on postoperative opioid consumption and pain scores. Also, postoperative outcomes related to respiratory ( postoperative oxygenation and atelectasis score), hemodynamic functions ( newly developed arrhythmias), total postanesthesia care unit stay, and hospital stay will be questioned.

Detailed description

All patients will receive standard general anaesthesia under standard monitoring along with the bispectral index (Medtronic). Intubation will be performed by administering intravenous (IV) 0,03 mg/kg midazolam, propofol (Lipuro, Braun, max. 2 mg/kg according to BIS), two mcg/kg fentanyl (Talinat, VEM), 1 mg /kg rocuronium (Esmeron, Alessandroorsini) followed by 1 MAC sevoflurane (Sevorane, Abbott) in an air-oxygen mixture for maintenance of anaesthesia. Following anaesthesia induction, all participants will receive superficial parasternal intercostal plane block (SPIP) bilaterally along with 8 mg dexamethasone before surgical incision as part of multimodal analgesia by a single experienced regional anaesthesiologist (B.C.) under ultrasound guidance (Esaote MyLab ™ Seven). SPIPB will be performed using a high-frequency probe to visualize the pectointercostal fascial area at the intercostal level of the intercostal 3-4 level, and 20 ml %0,25 bupivacaine was injected bilaterally. After applying SPIPB, the surgery is set to begin after at least 15 minutes of block procedure. The intraoperative analgesic need will be supplied by fentanyl bolus doses as 50 mcq if necessary, as heart rate or systolic blood pressure increases by more than %15. According to randomization, the intervention group will receive RIFPB with 10 ml %0,25 bupivacaine. From the beginning of acclaimed arousal till the 24th hour, rescue analgesia as tramadol 100 mg (maximum daily dose 400 mg) is applied if NRS is over four or with the patient's request. The routine analgesia regimen was 1 gram IV paracetamol 6th hourly postoperatively at the PACU. All patients were followed up from the extubation time till hospital discharge to evaluate respiratory and hemodynamic changes, possible complications and total postoperative time.

Conditions

• Coronary Artery Disease
• Peripheral Nerve Blocks
• Sternotomy

Interventions

Type	Name	Description
PROCEDURE	The recto intercostal fascial plane block	After ensuring aseptic conditions, the high-frequency linear ultrasound probe was used to detect the rectus abdominis muscle and the 6-7th costal cartilage as described by Tulgar et al. After rotating and shifting the transducer, 6-7th costal cartilages, the rectus abdominis muscle, and intercostal muscles between the cartilages were confirmed. The primary investigator (B.C.) directed the needle tip caudad in the cephalic direction in-plainly, and 20 ml 0,25% bupivacaine was injected bilaterally into the plane between the costal cartilage and the rectus abdominis muscle following negative aspiration.

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-05-01
• Completion: 2025-06-01
• First posted: 2024-05-16
• Last updated: 2025-03-19

Locations

1 site across 1 country: Turkey (Türkiye)