Comparison of Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block

NCT ID: NCT06407037

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-27
• Study Completion Date: 2025-02-17

Brief Summary

Breast cancer is the most common malignancy in women. Modified radical mastectomy, a surgical procedure in the treatment of breast cancer, is one of the standard treatments. Postoperative pain can seriously reduce the quality of life in patients, and inadequately treated acute pain can trigger chronic pain syndrome. Therefore, thoracic paravertebral block and thoracic epidural block are effective in postoperative analgesia. However, the use of these blocks is limited due to complications. In recent years, less invasive blocks, such as pectoral nerve block (PECS I-II), Serratus anterior plane block (SAPB), Erector spinae plane block (ESPB), and Serratus Posterior Superior intercostal Plane Block (SPSİPB) have been applied. In this study, it was aimed to compare the analgesic effectiveness of ESPB and SPSİPB applications in patients undergoing breast surgery.

Detailed Description

Postoperative pain will be assessed during resting and coughing with a visual analog scale (0-10 cm) and nausea and vomiting with a Postoperative Nausea Vomiting Score at the postoperative 1, 4, 8, 12, and 24 hours. The amount of tramadol consumed in the postoperative period will be recorded. Patient satisfaction will be assessed with the Likert scale at postoperative 24 hours.

Conditions

Erector Spinae Plane Block; Serratus Posterior Superior Intercostal Plane Block; Acute Pain; Postoperative Pain; Breast Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Erector Spinae Plane Block

Following the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the erector spinae muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 30 ml of 0.25% bupivacaine was injected into the area.

Group Type: ACTIVE_COMPARATOR

Erector Spinae Plane Block

Intervention Type: PROCEDURE

Erector Spinae Plane Block will be performed unilaterally, under US guidance, before the surgical operation, when the patient is placed in the lateral decubitus position. 30 ml of 0.25% bupivacaine will be used in applications.

Serratus Posterior Superior Intercostal Plane Block

The probe was placed on the spinae scapula in the sagittal plane to identify the second and third ribs. The trapezius, rhomboid, serratus posterior superior muscle were visualized. The needle was inserted just above the third rib deeply into the serratus posterior superior muscle. Two mL isotonic was administrated for the correction. Then, 30 mL of 0.25% bupivacaine was administrated between serratus posterior superior muscle and rib.

Group Type: ACTIVE_COMPARATOR

Serratus Posterior Superior Intercostal Plane Block

Intervention Type: PROCEDURE

Serratus Posterior Superior Intercostal Plane Block will be performed unilaterally, under US guidance, before the surgical operation, when the patient is placed in the lateral decubitus position. 30 ml of 0.25% bupivacaine will be used in applications.

Interventions

Erector Spinae Plane Block

Erector Spinae Plane Block will be performed unilaterally, under US guidance, before the surgical operation, when the patient is placed in the lateral decubitus position. 30 ml of 0.25% bupivacaine will be used in applications.

Intervention Type: PROCEDURE

Serratus Posterior Superior Intercostal Plane Block

Serratus Posterior Superior Intercostal Plane Block will be performed unilaterally, under US guidance, before the surgical operation, when the patient is placed in the lateral decubitus position. 30 ml of 0.25% bupivacaine will be used in applications.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Those aged 18-65
• Those with ASA scores I-II-III
• Those with a body mass index (BMI) between 18-35
• Patients who will undergo breast surgery

Exclusion Criteria

• Those under the age of 18 and over the age of 65
• Those with ASA score IV and above
• Those with a history of allergy to the drugs to be blocked
• Those with a history of bleeding diathesis
• Patients with infection in the area to be blocked
• Those with a BMI below 18 and above 35
• Patients who underwent surgery under emergency conditions

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Diskapi Yildirim Beyazit Education and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Emine Arik

Principal İnvestigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara Etlik City Hospital

Yenimahalle, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AEŞH-EK1-2023-824

Identifier Type: -

Identifier Source: org_study_id