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临床试验/NCT04306133
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

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

发起方
Campus Bio-Medico University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giuseppe Pascarella

Principal Investigator

Campus Bio-Medico University

研究点 (1)

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