Recto-intercostal Block for Coronary Artery Bypass Grafting

Not Applicable

Active, not recruiting

• Conditions: Peripheral Nerve Blocks; Sternotomy; Coronary Artery Disease
• Interventions: Procedure: The recto intercostal fascial plane block

• Registration Number: NCT06418100
• Lead Sponsor: Haseki Training and Research Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2024-02-26
• Study Start: 2024-03-01
• Study First Submitted QC: 2024-05-13
• Study First Posted: 2024-05-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-19
• Primary Completion: 2025-05-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patients who will undergo CABG surgery with sternotomy
• patients who have an American Society of Anesthesiologists (ASA) Physical Status classification of III to IV

Exclusion Criteria

• refusal to participate
• a history of neurological deficits or neuropathy affecting the thoracal innervation
• infection at the site of block application
• allergy to local anesthetics
• epilepsy or treatment with antipsychotics
• abuse of alcohol or drugs
• previous surgery distorting the anatomy of the sternum, thorax or upper abdominal area
• severe organ dysfunction ( kidney, liver and other); patients who fail at weaning after 12 hours of surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The rectointercostal fascial plane block	The recto intercostal fascial plane block	The participants will receive postoperative recto intercostal fascial plane block, with 20 ml 0,25 bupivacaine bilaterally.

Primary Outcome Measures

Name	Time	Method
Total rescue analgesic	postoperative 24 hour	. 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 over 4 or with the patient's request.

Secondary Outcome Measures

Name	Time	Method
intraoperative opioid use	intraoperative	total amount of opioid use as fentanyl intraoperatively
postoperative arythmias	postoperative 48 hour	postoperative arythmias especially atrial fibrillation
postoperative respiratory function	postoperative 48 hour	postoperative atelectasis score
intraoperative hemodynamic change	at sternotomy	systolic blood pressure

Trial Locations

Locations (1)

Haseki Training and Research Hospital; 🇹🇷 Istanbul, Sultangazi, Turkey