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临床试验/NCT03872843
NCT03872843已完成4 期

A Prospective Double Blind Randomized Control Trial Comparing Opioid to Non-Opioid Protocol in Managing Postoperative Pain After Ureteroscopy With Stent Placement

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年9月19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
已完成
入组人数
22
试验地点
1
主要终点
Amount of Pain Medication Used

研究概览

简要总结

The purpose of this research study is to compare how well two medications work to control post-operative pain.

详细描述

This will be a randomized double blinded control trial with subjects randomized to either opioid group (Norco 5-325 milligram) or a non-opioid group (Ibuprofen 400 milligram). Subjects with a renal stones who are consented for a ureteroscopy will be eligible for the study. Subjects eligible for the study will have a discussion with the study team member about treatment options. Subjects can either elect not to be in the study and actively choose which treatment is preferable, or the subject can choose to enter the study and be randomized to one of these treatment arms. The ureteroscopy will be performed using standard of care instruments and techniques. No changes to operative technique will be performed for subjects in the study vs regular patients undergoing the same procedure. Post operatively; investigators plan to discharge all subjects home from the recovery unit. All subjects will be seen one week after surgery for follow up, questioner filling and stent removal.

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
Double (Participant, Investigator)

盲法说明

Double-blinded

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

  • Ureteroscopy performed for renal stones
  • Age over 18 years
  • Two kidneys

排除标准

  • Solitary Kidney
  • Poor kidney function (GFR<30)
  • Allergy to either Ibuprofen or Norco
  • Pelvic Kidney

研究组 & 干预措施

Opioid Group

Active Comparator

This group includes subjects with renal stones who are consented for a ureteroscopy. They will be randomized to Norco 5milligram-325milligram Tablet for postoperative pain after ureteroscopy with stent placement.

干预措施: Norco 5milligram-325milligram Tablet (Drug)

Non-Opioid Group

Active Comparator

This group includes subjects with renal stones who are consented for a ureteroscopy. They will be randomized to Ibuprofen 400 milligram for postoperative pain after ureteroscopy with stent placement.

干预措施: Ibuprofen 400 MILLIGRAM in 1 TABLET ORAL TABLET, FILM COATED (Drug)

结局指标

主要结局

Amount of Pain Medication Used

时间窗: between baseline through day 7

Number of tablets taken after surgery

Number of Subjects Who Need Additional Pain Medication and/or Refill

时间窗: baseline through day 7

Number of Subjects Who Need Additional Pain medication and/or Refill

次要结局

  • Urinary Index(day 7)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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