Combined SAPB in MICS

NCT ID: NCT06326320

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-07
• Study Completion Date: 2025-06-25

Brief Summary

Minimally invasive cardiac surgery (MICS) has begun to be performed frequently in recent years. Compared to sternotomy, MISC reduces the risk of mediastinitis, leaves a more aesthetic scar, facilitates postoperative rehabilitation, and shortens the hospital stay. MICS requires a thoracic incision in the right 4th or 5th intercostal space. This incision causes intense and long-lasting pain in the postoperative period. Pain is exacerbated by breathing movements, coughing, and respiratory physiotherapy.

Postoperative analgesia is a critical risk factor for the development of pulmonary and cardiovascular complications in any type of cardiothoracic 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, thoracic epidural analgesia has been avoided due to the use of intraoperative high-dose heparin. As an alternative, peripheral nerve blocks have recently gained popularity. SAPB is one of them. SAPB can be applied in three ways. While deep SAPB (DSAPB) is applied under the serratus anterior muscle, superficial SAPB (SSAPB) is applied above the serratus anterior muscle. Combined SAPB (CSAPB) is applied both below and above the serratus anterior muscle. These blocks can be performed with a single injection anywhere between the second and seventh ribs on the lateral chest wall.

In this study, the analgesic effects of ultrasound-guided CSAPB application in patients undergoing MICS will be evaluated.

Conditions

Serratus Anterior Plane Block; Acute Pain; Postoperative Analgesia; Minimal Invasive Cardiac Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combined serratus anterior plane block

Following the visualization of the anatomical structures, the nerve block needle will be advanced via the in-plane technique beneath the serratus anterior muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine will be injected into the area. Then, with the same needle, will be returned 1-2 cm from the deep serratus anterior area to superficial serratus anterior area above the serratus anterior muscle and will be injected 2 ml normal saline for hydrodissection. Finally 20ml of 0.25% bupivacaine will be injected for superficial serratus anterior block into the interfacial area.

Group Type: OTHER

Combined SAPB

Intervention Type: PROCEDURE

Combined Deep and Superficial Serratus Anterior Plane Block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, when the patient is placed in the supine position. 40 ml of 0.25% bupivacaine will be used in applications.

Interventions

Combined SAPB

Combined Deep and Superficial Serratus Anterior Plane Block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, when the patient is placed in the supine position. 40 ml of 0.25% bupivacaine will be used in applications.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 18 to 80 years old
• American Society of Anesthesiologists (ASA) physical status I-II-III
• BMI 18 to 40 kg/m2
• Elective Minimally Invasive Cardiac Surgery (MICS)

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

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Nilgün Zengin

Principal İnvestigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara City Hospital

Çankaya, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E.Kurul-E2-24-6175

Identifier Type: -

Identifier Source: org_study_id