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Completed

NCT Number: NCT06407037

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

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.

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Key information

Conditions

Erector Spinae Plane Block Acute Pain Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Serratus Posterior Superior Intercostal Plane Block Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Etlik City Hospital

Yenimahalle, Ankara, 06170, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Postoperative analgesia

    Time frame: Postoperative day 1

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

Secondary outcomes

  1. Postoperative tramadol consumption

    Time frame: Perioperative day 1

    The amount of tramadol consumed in the postoperative period will be recorded

  2. Patient satisfaction

    Time frame: Postoperative 24th hour

    Satisfaction will be assessed with a 5 point Likert scale (0-4 whereas 0:definitely disagree; 1:slightly agree; 3: agree; 4: strongly agree)

Sponsors and collaborators

Lead sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Other Gov

Registry information

Official study title

Comparison of the Effects of Ultrasound-Guided Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block on Postoperative Acute Pain in Patients Undergoing Breast Surgery

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 9, 2024
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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