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

Not Applicable

Completed

• Conditions: Erector Spinae Plane Block

• Registration Number: NCT07134933
• Lead Sponsor: Inonu University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-12-25
• Primary Completion: 2019-03-01
• Study Completion: 2019-04-20
• Status Verified: 2025-08
• Study First Submitted: 2025-08-14
• Study First Submitted QC: 2025-08-14
• Last Update Submitted: 2025-08-14
• Study First Posted: 2025-08-21
• Last Update Posted: 2025-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Remifentanil Consumption	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 Outcome Measures

Name	Time	Method
The VAS scores	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.
patient satisfaction	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.
postoperative morphine consumption	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.

Trial Locations

Locations (1)

İnonu University Medicine Faculty Turgut ozal Medical Center; 🇹🇷 Malatya, Turkey