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临床试验/NCT07134933
NCT07134933已完成不适用

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

Inonu University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2018年12月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
1
主要终点
Remifentanil Consumption

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •the patients who undergone unilateral surgery due to breast tumors

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: ESP (erector spinae plane)block (Procedure)

Group II

No Intervention

The group without ESP block was defined as Group II.

结局指标

主要结局

Remifentanil Consumption

时间窗: 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.

次要结局

  • The VAS scores(from the end of the surgery to 24 hours of postoperative)
  • patient satisfaction(at the 24th postoperative hour)
  • postoperative morphine consumption(from the end of the surgery to 24 hours of postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mukadder Sanli

Associate professor

Inonu University

研究点 (1)

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