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

NCT07134933 | Completed

• 1 other identifier: ESP Block
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Erector Spinae Plane Block

Keywords

Erector spinae plane block; patient satisfaction; breast surgery; postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• Remifentanil Consumption

  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.

  From beginning of anesthesia to finished the surgery

Secondary Outcomes (3)

• postoperative morphine consumption

  from the end of the surgery to 24 hours of postoperative

• The VAS scores

  from the end of the surgery to 24 hours of postoperative

• patient satisfaction

  at the 24th postoperative hour

Study Arms (2)

Group I

ACTIVE COMPARATOR

The group with ESP block was defined as Group 1. The ESP block was performed unilaterally in the direction of the surgery.

Procedure: ESP (erector spinae plane)block

Group II

NO INTERVENTION

The group without ESP block was defined as Group II.

Interventions

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.

Group I

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Since patients were required to undergo breast surgery, only female gender was included in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

İnonu University Medicine Faculty Turgut ozal Medical Center

Malatya, 44100, Turkey (Türkiye)

Location

Related Publications (1)

• Wick EC, Grant MC, Wu CL. Postoperative Multimodal Analgesia Pain Management With Nonopioid Analgesics and Techniques: A Review. JAMA Surg. 2017 Jul 1;152(7):691-697. doi: 10.1001/jamasurg.2017.0898.

  PMID: 28564673 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Parapsychology

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Behavioral Sciences; Behavioral Disciplines and Activities

Study Officials

• Mukadder Sanli, Associate Professor

  Inonu University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 21, 2025
• Study Start: December 25, 2018
• Primary Completion: March 1, 2019
• Study Completion: April 20, 2019
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)