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临床试验/NCT06278987
NCT06278987招募中4 期

Comparison of Cryoablation of Pericapsular Nerve Group (PENG) to Fascia Iliaca Catheter in Patients With a Hip Fracture

University of Minnesota1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
150
试验地点
1
主要终点
Maximum pain score on Post-operative day 30

研究概览

简要总结

The purpose of this study is to determine if patients with hip fractures who undergo cryoablation of the PENG have improved pain control 30 days from surgery when compared to those who have a fascia iliaca catheter.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing hip fracture repair aged 18-85.

排除标准

  • Patients who have an exclusion to regional anesthesia.
  • Patients who are pregnant assessed via self-report or pregnancy test if they have taken one.
  • Non-English speakers
  • Patients who already had their fracture repaired"

研究组 & 干预措施

PENG block and cryoablation

Experimental

Patients undergoing hip fracture repair aged 18-85

干预措施: PENG block and cryoablation (Drug)

fascia iliaca compartment block

Experimental

Patients undergoing hip fracture repair aged 18-85

干预措施: fascia iliaca compartment block (Drug)

结局指标

主要结局

Maximum pain score on Post-operative day 30

时间窗: 30 days post surgery

Maximum pain score on day 30 post surgery. Pain Scale is 0-10 with 0 meaning no pain (better outcome) and 10 meaning worst pain imaginable (worse outcome).

Time to first ambulation

时间窗: 30 days post surgery

measured in Days:Hours:Minutes post operation

Opioid use

时间窗: day 0, 1, 2, 3, 4, 5, 6, 7 post surgery

Opioid use and Functional Pain scores on POD 0, 1, 2, 3, 4, 5, 6, 7 - measured in milligrams morphine equivalents

number of patients using opioids

时间窗: 30 days post surgery

measured in number of patients

Length of Hospital Stay

时间窗: 30 days post surgery

measured in number of days

functional pain scores

时间窗: day 0, 1, 2, 3, 4, 5, 6, 7 post surgery post surgery

Functional Pain Score on Post Operative Day 0, 1, 2, 3, 4, 5, 6, 7 - measured with Pain Scale 0-10 with 0 meaning no pain (better outcome) and 10 meaning worst pain imaginable (worse outcome)

Number of patients returned home by Post Operative Day 30

时间窗: 30 days post surgery

measured in number of patients

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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