NCT04306133已完成不适用
Pericapsular Nerve Group (PENG) Block Combined to Wound Infiltration vs. Wound Infiltration Alone for Postoperative Analgesia After Total Hip Replacement: a Prospective Controlled Trial
Campus Bio-Medico University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年3月9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
- 60
- 试验地点
- 1
- 主要终点
- Maximum Pain Score
研究概览
简要总结
This study analyze the effect of Pericapsular Nerve Group (PENG) Block combined to wound infiltration for analgesia after elective hip replacement.
Half of participants will receive a PENG Block combined with wound infiltration, while the other half will receive wound infiltration alone.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective hip replacement surgery
- •ASA physical status score < 4
排除标准
- •Contraindications to regional anesthesia
- •ASA physical status score ≥ 4
- •Patient's refusal or inability to sing the informed consent
- •Pre-operatively therapy with opioids
- •Allergies to any drug provided by the study protocol
结局指标
主要结局
Maximum Pain Score
时间窗: 24 hours
A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[100-mm scale\]) will be used to evaluate pain during 48 h after surgery
Total opioids consumption
时间窗: 48 hours
Total of Sublingual Sufentanil tablets released
次要结局
- Incidence of block complications(48 hours)
- Opioids side effects(48 hours)
- Time to first opioid(48 hours)
- Range of hip motion(24 hours)
- Time to ambulation(48 hours)
- Quadriceps weakness(48 hours)
研究者
Giuseppe Pascarella
Principal Investigator
Campus Bio-Medico University
研究点 (1)
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