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

NCT06407037 | Completed

• 1 other identifier: AEŞH-EK1-2023-824
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Postoperative analgesia

  Pain will be assessed with a visual analog scale (0-10 cm)

  Postoperative day 1

Secondary Outcomes (2)

• Postoperative tramadol consumption

  Perioperative day 1

• Patient satisfaction

  Postoperative 24th hour

Study Arms (2)

Erector Spinae Plane Block

ACTIVE COMPARATOR

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.

Procedure: Erector Spinae Plane Block

Serratus Posterior Superior Intercostal Plane Block

ACTIVE COMPARATOR

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.

Procedure: Serratus Posterior Superior Intercostal Plane Block

Interventions

Erector Spinae Plane Block 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.

Erector Spinae Plane Block

Serratus Posterior Superior Intercostal Plane Block 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.

Serratus Posterior Superior Intercostal Plane Block

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diskapi Yildirim Beyazit Education and Research Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Yenimahalle, Ankara, 06170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Pain; Pain, Postoperative; Breast Neoplasms

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal İnvestigator

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: December 27, 2023
• Primary Completion: February 3, 2025
• Study Completion: February 17, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

TU (1)