Combination of Parasternal and Serratus Anterior Plane Block in Coronary Artery Bypass Graft Surgery

NCT ID: NCT06326333

Last Updated: 2024-04-22

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

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-07

Study Completion Date

2024-04-18

Brief Summary

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

Postoperative analgesia is a critical risk factor for the development of pulmonary and cardiovascular complications in coronary artery bypass graft (CABG) surgery. If patients with high pain levels cannot breathe effectively, it may lead to atelectasis, cardiac ischemia, and arrhythmias. This prolongs the time it takes for patients to be discharged and increases the frequency of postoperative pulmonary complications and postoperative morbidity.

In addition to intravenous medications, various neuraxial and peripheral nerve blocks can be used in cardiac surgery. In recent years, neuraxial anesthesia has been avoided due to the use of intraoperative high-dose heparin. As an alternative, peripheral nerve blocks have recently gained popularity. Parasternal block (PSB) and serratus anterior plane block (SAPB) are very superficial and easy to reach. Recently, in the literature, the number of cases performed with these blocks under ultrasound guidance and the number of randomized controlled prospective studies have increased.

With this study, it was aimed to observe the analgesic effects on both the sternum and the drain site by applying PSB and SAPB applications simultaneously in the postoperative analgesia of CABG patients.

Detailed Description

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

Conditions

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

Parasternal Block Serratus Anterior Plane Block Acute Pain Postoperative Analgesia Cardiac Surgery

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Combined parasternal block and serratus anterior plane block

In the parasternal block application, the needle will be advanced under the pectoralis major muscle and above the intercostal muscle with the ultrasound-guided in-plane technique. 7.5 ml of 0.25% bupivacaine will be injected into this area per each level, at the level of the second and fourth intercostal space.

Then, in the serratus anterior plane block application, in the anterior axillary line, the needle will be advanced under the serratus anterior muscle, above the sixth rib, with the in-plane technique under ultrasound guidance. 10 ml of 0.25% bupivacaine will be injected into this area.

The application will be applied bilaterally.

Group Type OTHER

Combined parasternal block and serratus anterior plane block

Intervention Type PROCEDURE

The first PSB will be applied to the patients with 7.5 ml of 0.25% bupivacaine under real-time ultrasound guidance at the level of the second intercostal space.

The second PSB will be applied to the patients with 7.5 ml of 0.25% bupivacaine under real-time ultrasound guidance at the level of the fourth intercostal space.

The SAPB will be applied to the patients with 10 ml of 0.25% bupivacaine under real-time ultrasound guidance at the level of the sixth rib in the anterior axillary line.

The block applications will be applied bilaterally.

Interventions

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

Combined parasternal block and serratus anterior plane block

The first PSB will be applied to the patients with 7.5 ml of 0.25% bupivacaine under real-time ultrasound guidance at the level of the second intercostal space.

The second PSB will be applied to the patients with 7.5 ml of 0.25% bupivacaine under real-time ultrasound guidance at the level of the fourth intercostal space.

The SAPB will be applied to the patients with 10 ml of 0.25% bupivacaine under real-time ultrasound guidance at the level of the sixth rib in the anterior axillary line.

The block applications will be applied bilaterally.

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* 18 to 80 years old
* American Society of Anesthesiologists (ASA) physical status I-II-III
* BMI 18 to 30 kg/m2
* Elective coronary artery bypass graft (CABG) surgery

Exclusion Criteria

* Patient refusing the procedure
* Emergency surgery
* History of chronic opioid or analgesic used
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nilgün Zengin

Principal İnvestigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ankara City Hospital

Çankaya, Ankara, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

E.Kurul-E2-24-6176

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Safe Early Mobilization on CABG
NCT07276971 COMPLETED NA
CABG Without the Use of CPB
NCT00202332 COMPLETED PHASE2