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NCT Number: NCT06418100

Recto-intercostal Block for Coronary Artery Bypass Grafting

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haseki Training and Research Hospital

Istanbul, Sultangazi, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The recto intercostal fascial plane block

Procedure

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.

Primary outcomes

  1. Total rescue analgesic

    Time frame: 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 outcomes

  1. intraoperative opioid use

    Time frame: intraoperative

    total amount of opioid use as fentanyl intraoperatively

  2. intraoperative hemodynamic change

    Time frame: at sternotomy

    systolic blood pressure

  3. postoperative respiratory function

    Time frame: postoperative 48 hour

    postoperative atelectasis score

  4. postoperative arythmias

    Time frame: postoperative 48 hour

    postoperative arythmias especially atrial fibrillation

Other outcomes

  1. total hospital stay

    Time frame: postoperative

    up to discharge postoperative

Sponsors and collaborators

Lead sponsor

Haseki Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 16, 2024
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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