Recto-intercostal Block for Coronary Artery Bypass Grafting

NCT06418100 | Active Not Recruiting

• 1 other identifier: 272-2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Peripheral Nerve Blocks; Sternotomy

Keywords

coronary artery bypass grafting; Parasternal intercostal plane block; Recto-intercostal fascial plane block; Postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• intraoperative opioid use

  intraoperative

• intraoperative hemodynamic change

  at sternotomy

• postoperative respiratory function

  postoperative 48 hour

• postoperative arythmias

  postoperative 48 hour

Other Outcomes (1)

• total hospital stay

  postoperative

Study Arms (2)

The Control

NO INTERVENTION

The participants will have standardized anaesthesia management and receive postoperative rescue analgesia as morphine.

The rectointercostal fascial plane block

EXPERIMENTAL

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

Procedure: The recto intercostal fascial plane block

Interventions

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.

The rectointercostal fascial plane block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Sultangazi, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 37295124 BACKGROUND

• 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.

  PMID: 38375661 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Berna Caliskan

  Haseki Training and Research Hospital Anesthesiology and Reanimation Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants under general anaesthesia and the cardiovascular surgeon responsible for the study were blinded to the study groups. This surgeon served as the sole evaluator of postoperative outcomes. Intraoperative results were recorded by the anaesthesia technician, who was present in the operating room and unaware of the block procedures performed. Moreover, the data analysis was conducted before the unblinding of the data.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, randomized, triple-blind, controlled

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: May 16, 2024
• Study Start: March 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)