The Effect of Shotblocker on Pain and Patient Satisfaction for Spinal Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Assessment of pain during spinal needle insertion with 10 cm VAS (Visual Analog Scale)
研究概览
简要总结
This was a single-blind, randomized controlled trial. Seventy-six patients who underwent spinal anesthesia for surgery were randomized into the Shotblocker group or Control group. Before the insertion of a 25-gauge spinal needle, Shotblocker was applied just before the spinal needle insertion in the Shotblocker group. 10-cm visual analog scale to evaluate the pain intensity of spinal needle insertion and a five-point scale for patient satisfaction were compared between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing surgery
排除标准
- •contraindications to regional anesthesia
- •refusal of the patient's regional anesthesia
- •intellectual disabilities that prevented completion of a visual analog scale (VAS)
研究组 & 干预措施
Shotblocker Group
Patients spinal injections were performed with Shotblocker placed onto injection site
干预措施: Shotblocker (Procedure)
Placebo Group
Patients spinal injections were performed without Shotblocker
干预措施: Placebo (Procedure)
结局指标
主要结局
Assessment of pain during spinal needle insertion with 10 cm VAS (Visual Analog Scale)
时间窗: 2 minutes
Assessment of pain during spinal needle insertion will be marked on 10 cm VAS scale 0-10 ( 0:no pain 10:Worst possible pain ) by the patient and will be measured
次要结局
- Five point scale for anesthesists satisfaction(1 minutes)
- Five point scale for patient satisfaction(1 minutes)
研究者
Gökhan İNANGİL
Principal Investigator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey