Recto-intercostal Block for Coronary Artery Bypass Grafting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block in Postoperative Pain Management After Coronary Artery Bypass Grafting

NCT07287761

Postoperative Pain After Thoracic Surgery Coronary Artery Bypass Graft (CABG)

RECRUITING

Recto-intercostal Fascial Plane Block and Pecto-intercostal Fascial Plane Block for Cardiac Surgery

NCT06285773

Cardiac Disease

COMPLETED NA

Comparison of the Analgesic Efficacy of Chest Wall Blocks in Coronary Artery Bypass Surgery

NCT06657261

Coronary Arterial Disease (CAD) Serratus Anterior Muscle Plane Block Transversus Thoracis Muscle Plane Block +1 more

ACTIVE_NOT_RECRUITING NA

The Efficacy of PSB and Recto-intercostal Block Combination on Postoperative Pain in Patients Undergoing Cardiac Surgery Via Sternotomy: Case Series

NCT06553560

Post Operative Pain

NOT_YET_RECRUITING NA

Efficacy of Parasternal Blocks in Cardiovascular Surgery Patients Undergoing Median Sternotomy

NCT06387095

Postoperative Pain

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease Peripheral Nerve Blocks Sternotomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective, randomized, triple-blind, controlled

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

The Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

The rectointercostal fascial plane block

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

Group Type EXPERIMENTAL

The recto intercostal fascial plane block

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No