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NCT Number: NCT07747623

One-level and Bi-level ESPB Application in Patients Undergoing Breast Surgery

Acute pain after breast surgery can significantly reduce the quality of life for patients. If acute pain is not adequately treated, it can develop into chronic pain. Thoracic epidural analgesia, thoracic paravertebral block, erector spinae plane block, and serratus anterior plane block are frequently applied blocks. However, ESPB, being a fascial plane block, can yield inconsistent results regarding distribution and dermatomal area. In recent years, there has been an increase in publications applying ESPB from two levels to achieve wider distribution. As a result, this study aims to compare the analgesic efficacy of single-level (Thoracic 3) and two-level (Thoracic 2, Thoracic 4) ESPB applications.

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Key information

Conditions

Pain, Postoperative Breast Surgery Erector Spinae Plane Block Multimodal Analgesia Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 18 and 80 years
  • American Society of Anesthesiologists physical status I-II-III
  • Body mass index between 18 and 30 kg/m²
  • Patients undergoing elective breast surgery

Exclusion criteria

  • Patient refusing the procedure
  • History of chronic analgesic or opioid therapy
  • History of local anesthetic allergy
  • Infection in the intervention area

Treatment and study plan

One-level Erector Spinae Plane Block

Procedure

One-level Erector Spinae Plane Block will be performed unilaterally, under US guidance, before the surgical operation, and when the patient is placed in the lateral decubitus position. In applications, 30 ml of 0.25% bupivacaine will be injected at the T3 level.

Bi-level Erector Spinae Plane Block

Procedure

Bi-level Erector Spinae Plane Block will be performed unilaterally, under US guidance, before the surgical operation, and when the patient is placed in the lateral decubitus position. In applications, 15 ml of 0.25% bupivacaine at T2 level and 15 ml of 0.25% bupivacaine at T4 level will be injected.

Primary outcomes

  1. Pain scores

    Time frame: 4th-hour after surgery

    Pain will be assessed at the 4th-hour rest using the visual analog scale on a scale from 0 mm (no pain) to 100 mm (worst pain).

Secondary outcomes

  1. Pain scores

    Time frame: Up to 24 hours after surgery

    Pain will be assessed at rest using the visual analog scale on a scale from 0 mm (no pain) to 100 mm (worst pain). Pain assessment will be done at the 1st, 2nd, 12th, and 24th hours after surgery.

  2. Pain scores

    Time frame: Up to 24 hours after surgery

    Pain will be assessed while coughing using the visual analog scale on a scale from 0 mm (no pain) to 100 mm (worst pain). Pain assessment will be done at the 1st, 2nd, 6th, 12th, and 24th hours after surgery.

  3. Tramadol Consumption

    Time frame: Up to 24 hours after surgery

    Postoperative intravenous tramadol infusion therapy will be administered with the patient-controlled analgesia (PCA) method. Thanks to PCA, how much morphine the patient needs will be followed in mg.

  4. Side effects

    Time frame: Up to 24 hours after surgery

    Side effects, such as allergy to local anesthetics, hypotension, nausea/vomiting, and itching, will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Musa Zengin, Associate Professor

CONTACT

[email protected]

05307716235

Sponsors and collaborators

Lead sponsor

Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Other

Registry information

Official study title

Comparison of the Efficiency of One-Level and Bi-Level ESPB ESPB for Postoperative Analgesia in Patients Undergoing Breast Surgery

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

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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