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临床试验/NCT06608810
NCT06608810已完成不适用

Comparison of Efficacy in Pectoral Nerve Block Type II, Thoracic Paravertebral Block, and General Anesthesia Alone for Excision of Breast Fibroma: a Prospective Randomized Controlled Trial

Inner Mongolia Baogang Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年7月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Changes in visual analog scale scores

研究概览

简要总结

Patients were randomly assigned to the GA group, PECS II group, or TPVB group using a computer-generated random number table. Group assignments were kept in a sealed envelope, which was opened only after induction of general anesthesia on the day of surgery. This study was a double-blind trial, ensuring that neither the patients nor the investigators were aware of the analgesic method used. The same anesthesiologist was responsible for PECS II block or TPVB, while different anesthesiologists were responsible for anesthesia implementation and postoperative follow-up.

详细描述

Written informed consent was obtained from all participants.90 female patients aged 18 to 65 with ASA I-II status were selected at Baogang Hospital, Inner Mongolia, who had been diagnosed with breast fibroadenomas. Exclusion criteria included pre-existing infection at the site of block, coagulation disorders, morbid obesity (body mass index > 40 kg/m²), allergy to local anesthetics, impaired lung function, significant cardiac disease, renal dysfunction, pre-existing neurological disorders, and psychiatric conditions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

入选标准

  • Clinical diagnosis of breast fibromas

排除标准

  • heart attack mental disorder

研究组 & 干预措施

Comparison of efficacy in pectoral nerve block type II, thoracic paravertebral block, and general an

Other

干预措施: nerve block with 0.5% ropivacaine (Drug)

结局指标

主要结局

Changes in visual analog scale scores

时间窗: From enrollment to the end of treatment at 1 week

Zero is equivalent to no pain and 10 indicates the worst possible pain.\"

次要结局

未报告次要终点

研究者

发起方
Inner Mongolia Baogang Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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