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临床试验/NCT05427292
NCT05427292已完成不适用

Feasibilty of Serratus Anterior and Pectoral Nerve Blocks (PECS II) Combination as Main Anesthetic Method in Breast Cancer Surgery Patients

Samsun University1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2022年7月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
17
试验地点
1
主要终点
Sufficient surgical anesthesia

研究概览

简要总结

Aim of this study is to determine the success of combined serratus anterior and PECS-2 block as the main anesthetic method in breast cancer surgery and also to investigate the patient acceptability of this combination and its relationship with surgeon satisfaction.

详细描述

Breast conserving surgery or mastectomy is applied in the surgical treatment of breast cancer. Axillary interventions range from sentinal lymph node biopsy to lymph node dissection. Clinically significant acute pain develops following breast surgery in 35% of patients.

Today, regional anesthesia is widely used as an opioid-sparing strategy in the treatment of acute postoperative pain. New fascial plane blocks have been developed as alternative or complementary techniques for chest wall analgesia, including pectoral nerve blocks (PECS1-2) and serratus plane block.

In order to reduce the risk of perioperative morbidity and mortality and to meet the patient demand, the demand for awake surgery is increasing in institutions.

Therefore, a prospective observational case series was conducted to explain the efficacy, patient acceptability, and surgeon satisfaction of combined serratus anterior and PECS-2 block as the main anesthetic method for breast cancer surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients between the ages of 18-80 and ASA I-III who will undergo unilateral breast cancer surgery will be included in the study.

排除标准

  • Patients with previous breast surgery other than excisional biopsy,
  • coagulopathy,
  • bleeding disease,
  • local infection at the injection site,
  • history of local anesthetic allergy,
  • psychiatric disease (depression, mania, schizophrenia or antipsychotic drug use),
  • history of opioid use for more than 4 weeks
  • Patients with body mass index (BMI) >40kg/m2 and
  • chest deformity (pectus excavatum and pectus carinatum) will be excluded from the study.

结局指标

主要结局

Sufficient surgical anesthesia

时间窗: up to 30 minutes

After confirming the sensory block in the surgical area with the post-procedure pinpirick test, successful completion of the surgical procedure 'without the need for deep sedoanalgesia' will be considered 'sufficient surgical anesthesia'.

次要结局

  • Pain scores on the Numeric Rating Scale (NRS)(up to 24 hours)
  • quality of anesthesia(up to 2 hours)
  • scaling working conditions(up to 2 hours)
  • Quality of recovery 15 scale(up to 24 hours)
  • analgesic consumption(up to 24 hours)
  • modified Wilson Sedation Scale(up to 2 hours)

研究者

发起方
Samsun University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gamze Ertas

Principal Investigator

Samsun University

研究点 (1)

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