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NCT Number: NCT07134933

The Effects of Erector Spinae Plane Block on Pain Scores in Unilateral Breast Cancer Surgery

The high incidence of breast cancer is increasing the need for oncologic breast surgery. The optimal acute postoperative pain management after breast surgery is not yet clear. The erector spinae plane block (ESPB) is a newer and may be potentially safer alternative other regional analgesia techniques. We will investigate the effectiveness of ESP for managing acute pain after breast cancer surgery. Patients will randomise to receive either ESP block (Group1)or no ESP block (Group II). The primary outcome is postoperative pain scores used Visual Analog Scale (VAS), and the secondary outcomes include intraoperative opioid consumption postoperative total opioid consumption and patient satisfaction.

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Key information

Conditions

Erector Spinae Plane Block Behavior Health Behavior Patient Satisfaction Treatment Adherence and Compliance

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

İnonu University Medicine Faculty Turgut ozal Medical Center

Malatya, 44100, Turkey (Türkiye)

About this study

Anesthesia induction was achieved with propofol (2-3 mg kg-1), fentanyl (2 mcg kg-1), and rocuronium (0.6 mg kg-1). Anesthesia was maintained with Total intravenous anesthesia (TIVA) used remifentanil (0.25-0.5 mcg kg-1 min-1) and propofol (150 mcg kg-1 min-1). During maintenance, a fresh gas flow of 3 L with a mixture of 50% oxygen and 50% air was used. The BIS value was kept between 30-50.

Patients were divided into two groups according to a computer-based simple randomization method. Those who received a preoperative ESP block at the T4 vertebra level under ultrasound guidance were designated as Group I, while those who underwent surgery without the block were designated as Group II.

The ESP block was performed unilaterally in the direction of the surgery by the same anesthetist. Blocks were performed using an Esaote ultrasound device (Esaote My Lab 6 US machine, Florence, Italy), a multifrequency convex probe (1-8 MHz), and a 22-gauge, 50 mm facet needle (B. Braun Sonoplex, Melsungen, Germany) The block needle was placed at the level of the T4 spinal process using the in-plane approach, approximately 3 cm lateral to the T4 spinous process in the parasagittal plane. After visualizing the transverse process with the in-plane approach, the 50 mm facet needle (B. Braun Sonoplex, Melsungen, Germany) was inserted through the skin, and a test dose of 1 ml of 0.9% NaCl was injected between the fascia of the trapezius, rhomboid, and erector spinae muscles and the transverse vertebral process to confirm the location. A total of 20 ml of 0.5% bupivacaine was used as a local anesthetic. The cranial and caudal spread of the local anesthetic was monitored.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA I-II
  • the patients who undergone unilateral surgery due to breast tumors

Exclusion criteria

  • obesity (body mass index> 35 kg/m²)
  • infection at the needle entry site,
  • known allergy history to the medications to be used,
  • coagulopathy
  • a history of opioid use

Treatment and study plan

ESP (erector spinae plane)block

Procedure

The ESP block was performed unilaterally in the direction of the surgery by the same anesthetist. Blocks were performed using an Esaote ultrasound device (Esaote My Lab 6 US machine, Florence, Italy), a multifrequency convex probe (1-8 MHz), and a 22-gauge, 50 mm facet needle (B. Braun Sonoplex, Melsungen, Germany). The block needle was placed at the level of the T4 spinal process using the in-plane approach, approximately 3 cm lateral to the T4 spinous process in the parasagittal plane. After visualizing the transverse process with the in-plane approach, the 50 mm facet needle (B. Braun Sonoplex, Melsungen, Germany) was inserted through the skin, and a test dose of 1 ml of 0.9% NaCl was injected between the fascia of the trapezius, rhomboid, and erector spinae muscles and the transverse vertebral process to confirm the location. A total of 20 ml of 0.5% bupivacaine was used as a local anesthetic.

Primary outcomes

  1. Remifentanil Consumption

    Time frame: From beginning of anesthesia to finished the surgery

    The primary aim of our study was to compare perioperative remifentanil consumption between Group I patients who received a preoperative ESP block and Group II patients who underwent surgery without the block.

Secondary outcomes

  1. postoperative morphine consumption

    Time frame: from the end of the surgery to 24 hours of postoperative

    After extubation, a patient-controlled analgesia device containing morphine (0.5 mg/ml, 1 mg bolus, 8-minute lockout interval, maximum dose of 6 mg in 1 hour) was installed. The amount of morphine consumed in the postoperative 24 hours was measured.

  2. The VAS scores

    Time frame: from the end of the surgery to 24 hours of postoperative

    Postoperative pain assessment was conducted using the Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates unbearable pain) at rest and during movement at the 5, 15, 30, and 60 minutes, as well as at 2, 4, 6, 8, 16, and 24 hours post-surgery.

  3. patient satisfaction

    Time frame: at the 24th postoperative hour

    a four-point patient satisfaction score (1: poor, 2: fair, 3: good, 4: excellent) were evaluated by an anesthetist who was unaware of the study groups.

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

The Effects of Erector Spinae Plane Block on Pain Scores and Patient Experience in Unilateral Breast Cancer Surgery: A Prospective, Randomized Clinical Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 21, 2025
Registry last updated
Aug 21, 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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