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临床试验/NCT03623035
NCT03623035已完成不适用

Pilot Study on Pain and Sensation After Regional Anesthesia for Total Hip Arthroplasty

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年8月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Patient Pain Score With Activity

研究概览

简要总结

This study aims to determine spinal resolution and pain levels after the placement of a lumbar plexus block (LPB) and spinal for total hip replacement procedure. This is a pilot study that looks to collect information in order to design a larger, more significant study comparing Quadratus Lumborum blocks (QLB) and Lumbar Plexus blocks.

详细描述

The Quadratus Lumborum block (QLB) is a newer regional analgesic technique that may be as effective as Lumbar Plexus blocks (LPB) at providing pain control following direct anterior approach (DAA) hip arthroplasty. The purpose of this study is to collect pilot data to help the design of a future randomized study, comparing a QLB to a LPB for DAA procedures. The investigators will assess for spinal resolution below the level of L5/S1 by assessing the presence of pin prick sensation at these levels. This will help determine if pain scores collected at 6hrs reflect analgesia provided by the preoperative LPB alone or if the data is confounded by the presence of spinal anesthesia. This data will help us determine if 6hrs is a feasible primary endpoint to assess pain scores. Additionally, assuming that spinal regression is complete by 6hrs, the VAS pain scores obtained will then be used to perform a power analysis to determine the necessary study size when comparing QLB to LPB for DAA hip arthroplasty.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patients that have elective total hip arthroplasty with DAA at Davie Medical Center.

排除标准

  • Patients will be excluded if they do not receive a lumbar plexus block and spinal anesthesia.
  • and/or if they have peripheral neuropathy affecting their feet.

结局指标

主要结局

Patient Pain Score With Activity

时间窗: 6 Hours post block placement

Pain scores will be measured on a verbal pain score when participant sits up in bed. Totals Score range 0-10. Lower scores denote better outcomes.

次要结局

  • Patient Pain Scores at Rest(6 Hours post block placement)
  • Number of Participants Reporting Pin Prick Sensation(6 Hours post block placement)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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