Clinical trial NCT06418100: Recto-intercostal Block for Coronary Artery Bypass Grafting
Official title: Recto-intercostal Fascial Plane Block for Postoperative Analgesia in Coronary Artery Bypass Grafting With Sternotomy: a Randomized, Double-blind, Controlled Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Peripheral Nerve Blocks
Sternotomy
Keywords: coronary artery bypass grafting
Parasternal intercostal plane block
Recto-intercostal fascial plane block
Postoperative analgesia
Lead sponsor: Haseki Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized, triple-blind, controlled
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total rescue analgesic
timeFrame: postoperative 24 hour
Secondary outcomes:
measure: intraoperative opioid use
timeFrame: intraoperative
measure: intraoperative hemodynamic change
timeFrame: at sternotomy
measure: postoperative respiratory function
timeFrame: postoperative 48 hour
measure: postoperative arythmias
timeFrame: postoperative 48 hour
Other outcomes:
measure: total hospital stay
timeFrame: postoperative
Locations:
city: Istanbul
country: Turkey
facility: Haseki Training and Research Hospital
state: Sultangazi
Study officials:
affiliation: Haseki Training and Research Hospital Anesthesiology and Reanimation Department
name: Berna Caliskan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Alver S, Sakul BU, Ansen G, Pence KB, Alici HA. Recto-intercostal fascial plane block: Another novel fascial plane block. J Clin Anesth. 2023 Oct;89:111163. doi: 10.1016/j.jclinane.2023.111163. Epub 2023 Jun 7. No abstract available.
citation: Chen Y, Li Q, Liao Y, Wang X, Zhan MY, Li YY, Liu GJ, Xiao L. Preemptive deep parasternal intercostal plane block for perioperative analgesia in coronary artery bypass grafting with sternotomy: a randomized, observer-blind, controlled study. Ann Med. 2023;55(2):2302983. doi: 10.1080/07853890.2024.2302983. Epub 2024 Feb 20.