Recto-intercostal Block for Coronary Artery Bypass Grafting

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06418100
• Other study ID #: 272-2023
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: February 2024
• Source: Haseki Training and Research Hospital
• Contact: Berna Caliskan, MD
• Phone: +905067108770
• Email: caliskan.b[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 20 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Peripheral Nerve Blocks
• Sternotomy

Intervention

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.

Locations

Country	Name	City	State
Turkey	Haseki Training and Research Hospital	Istanbul	Sultangazi

Sponsors (1)

Lead Sponsor	Collaborator
Haseki Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	total hospital stay	up to discharge postoperative	postoperative
Primary	Total rescue analgesic	. 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.	postoperative 24 hour
Secondary	intraoperative opioid use	total amount of opioid use as fentanyl intraoperatively	intraoperative
Secondary	intraoperative hemodynamic change	systolic blood pressure	at sternotomy
Secondary	postoperative respiratory function	postoperative atelectasis score	postoperative 48 hour
Secondary	postoperative arythmias	postoperative arythmias especially atrial fibrillation	postoperative 48 hour