The Effect of Using Different Needle Sizes on Patient Comfort and Pain During the Sonographically Guided Fine Needle Biopsy of Thyroid Nodules: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 159
- 试验地点
- 2
- 主要终点
- Pain score immediately after biopsy
研究概览
简要总结
This randomized study compares patient pain and comfort during ultrasound-guided thyroid fine needle biopsy using 21-gauge versus 27-gauge needles. Patients with thyroid nodules were randomly assigned to one of two needle sizes. Pain intensity was measured immediately after the procedure using a 0-100 Visual Analog Scale. The study was conducted at İzmir Atatürk Training and Research Hospital between January 2024 and March 2024. The aim is to determine which needle size causes less pain and better patient comfort during the biopsy procedure.
详细描述
This prospective, randomized, single-blind clinical trial compares 21-gauge and 27-gauge needles for ultrasound-guided fine-needle biopsy of thyroid nodules. Participants are randomly assigned in a 1:1 ratio. The study aims to evaluate whether needle gauge affects patient pain and biopsy performance. Detailed eligibility criteria, outcome measures, and statistical analyses are provided in their respective sections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thyroid nodules requiring ultrasound-guided FNB with a maximum diameter ≥10 mm,
- •Intraglandular nodules with relatively central location within the thyroid gland
排除标准
- •Patient refusal to provide informed consent,
- •History of bleeding tendency or use of anticoagulant medication,
- •Substernal or subclavicular localization of the lesion in cases of large goiter.
研究组 & 干预措施
21-gauge needle group
Patients received ultrasound-guided thyroid fine needle biopsy using 21-gauge needle
干预措施: Thyroid fine needle biopsy with 21-gauge needle (Procedure)
27-gauge needle group
Patients received ultrasound-guided thyroid fine needle biopsy using 27-gauge needle
干预措施: Thyroid fine needle biopsy with 27-gauge needle (Procedure)
结局指标
主要结局
Pain score immediately after biopsy
时间窗: Immediately after the procedure
Pain intensity measured using 0-10 Visual Analog Scale (VAS) immediately after completion of ultrasound-guided thyroid fine needle biopsy. Higher scores indicate worse pain
Pain score immediately after biopsy
时间窗: In 5 minutes after the procedure
Pain intensity measured using 100-mm Visual Analog Scale immediately after completion of ultrasound-guided thyroid fine needle biopsy. Higher scores indicate worse pain
次要结局
- Diagnostic Adequacy Rate.(Time Frame: Within 14 days after biopsy)
研究者
Mehmet Yağtu, MD
Principal Investigator, MD
Izmir Ataturk Training and Research Hospital