Pain Management After Elective Shoulder Surgery: A Randomized Quantitative Study Comparing Hydromorphone With Piritramide
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Pain management after elective shoulder surgery
研究概览
简要总结
Postoperative pain management plays an important role in elective shoulder surgery. The aim of this randomized quantitative study is to compare two frequently used postoperative pain regimes (hydromorphone versus piritramide) regarding onset and duration after the effectiveness of the single-shot interscalene block has diminished.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients undergoing elective shoulder surgery with a single-shot interscalene plexus brachialis block in addition to general anesthesia
- •patients aged 18-99 years
- •patients being capable of giving an informed consent to participation in this study
排除标准
- •patients aged below 18 years
- •patients with decompensated liver, heart or renal insufficiency
- •patients with any kind of lung disease
- •patients with a chronic pain syndrome
- •patients with a previous pain medication with more than 3 drugs over more than 3 months
研究组 & 干预措施
Hydromorphone
Hydromorphone Hcl 4 milligram (mg) Tab 2 times after surgery as basic medication. Hydromorphone Hcl 2.6mg maximum 2 per 24h when numeric rating scale (NRS) > 5.
干预措施: Hydromorphone Hcl 4Mg Tab (Drug)
Piritramide
Piritramide 15mg s.c. 2 times after surgery as basic medication. Piritramide 7.5mg s.c. maximum 2 per 24h when numeric rating scale (NRS) > 5.
干预措施: Piritramide 15mg s.c. (Drug)
结局指标
主要结局
Pain management after elective shoulder surgery
时间窗: 6 months
Comparison of hydromorphone versus piritramide using the numeric rating scale (NRS; range 0 - 10 points; level 0 representing no pain; level 10 representing the highest pain level)
次要结局
未报告次要终点
研究者
Sandra Boesmueller, MD, PhD
Principal Investigator
AUVA Traumazentrum Vienna Site UKH Meidling