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临床试验/NCT05625802
NCT05625802已完成2 期

Erector Spinae Plane Block for Uncomplicated Renal Colic

University of Michigan1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2023年2月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
5
试验地点
1
主要终点
Participants Who Received a Second Parenteral Pain Medication in the Emergency Department (ED)

研究概览

简要总结

This research study is to determine how well the Erector Spinae Plane Block (ESPB) works for kidney stone pain and any possible side effects.

详细描述

When this trial was initially started, the intent was to compare the Erector Spinae Plane Block (ESPB) arm to data from electronic health records (EHR) of patients who had not received the ESPB. The EHR data was never obtained, so no comparison was conducted.

研究设计

研究类型
Interventional
分配方式
Non 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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Imaging confirmation of urolithiasis on the index encounter or prior encounter within 7 days
  • Patient received one dose of parenteral pain medication in the emergency department (ED)

排除标准

  • Pregnancy or breastfeeding
  • Prisoner or incarcerated individual
  • Therapeutic anticoagulation or coagulopathy.
  • Active treatment for urinary tract infection (either acute infection or chronic therapy)
  • Prior spinal surgery in the thoracic region
  • Allergy to local anesthetic or prior local anesthetic
  • Soft tissue infection overlying the injection site
  • Positive for coronavirus
  • Inability to communicate verbally or read/write in English
  • Currently taking strong CYP1A2 inhibitor (fluvoxamine, amiodarone, fluoroquinolones, etc.)
  • Glucose-6-phosphate dehydrogenase deficiency (G6PD)

研究组 & 干预措施

Erector Spinae Plane Block (ESPB)

Experimental

Intervention inhibits neurotransmission at the dorsal and ventral rami of the thoracic spinal nerves, providing anesthesia to multiple dermatomal levels

干预措施: Erector Spinae Plane Block (ESPB) (Procedure)

Erector Spinae Plane Block (ESPB)

Experimental

Intervention inhibits neurotransmission at the dorsal and ventral rami of the thoracic spinal nerves, providing anesthesia to multiple dermatomal levels

干预措施: Ropivacaine (Drug)

结局指标

主要结局

Participants Who Received a Second Parenteral Pain Medication in the Emergency Department (ED)

时间窗: By ED discharge, approximately 12 hours or less

Results reflect the number of participants who received a second parenteral pain medication after receiving one already. Data for this outcome was collected via electronic health record query.

次要结局

  • Change in Pain(Baseline, 5 minutes, and 60 minutes following procedure)
  • Rate of Admission to Hospital for Kidney Stones(Up to 30 days)
  • Rate of 24-hour and 72-hour Return to the Emergency Department (ED)(Up to 72 hours)
  • Emergency Department Length of Stay(Up to 30 days)
  • Safety Outcomes and Complications(Up to 30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher Fung

Assistant Professor in Emergency Medicine - Adult

University of Michigan

研究点 (1)

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