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临床试验/NCT03393364
NCT03393364已完成早期 1 期

Pain Management in Outpatient Urologic Procedures

University Hospitals Cleveland Medical Center1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2018年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
150
试验地点
1
主要终点
Pain control

研究概览

简要总结

Goal of this study is to evaluate how pain is controlled after outpatient urologic surgeries. Patients will receive either opioid pain medication or non-opioid medication for pain control. A survey will be conducted at the post-operative appointment to evaluate for pain control.

详细描述

Patients will be approached in the pre-operative area prior to their outpatient urologic surgery. Informed Consent will be obtained at that time. Patients will be instructed that they will receive a prescription for either opioid pain medication or non-opioid medication for after surgery. The opioid medication includes oxycodone, while the non-opioid includes ketoralac, a non-steroidal anti-inflammatory medication. Subjects will be assigned randomly to either medication. Standard of care after outpatient urologic surgery is either oxycodone or ketoralac, however there is no previous research on whether one is superior than the other. These drugs were chosen because they are the most commonly used medications after outpatient urologic surgery. The study team and patients will not be blinded to the treatment.

They will also receive instructions for non-opioid pain management. If the patients require additional pain medication after surgery, they are instructed to call the provider's office for further evaluation and treatment. The patient's physician will prescribe further medication if warranted. The post-operative appointment is scheduled 2-3 weeks after surgery. At the post-operative appointment, patients will then be given a four question paper survey inquiring how well their pain was managed, how many pills were taken, if any additional non-opioid medications were taken for pain, and how the extra pills were disposed. Other PHI that will be collected includes patient's age, gender, past medical history, past surgical history, renal function, prior medications, and current surgery.

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

  • outpatient urologic surgery
  • age 18 and over

排除标准

  • renal dysfunction
  • non-English speaking
  • employees of organization

研究组 & 干预措施

Opioid arm

Experimental

Patients receive opioid medication, oxycodone, after outpatient urologic surgery.

干预措施: Oxycodone (Drug)

Non-opioid arm

Experimental

Patients receive a non-opioid medication, ketorolac, after outpatient urologic surgery.

干预措施: Ketorolac (Drug)

结局指标

主要结局

Pain control

时间窗: within 6 weeks of surgery

Survey evaluating how well pain was controlled

次要结局

  • Number of pills used(within 6 weeks of surgery)

研究者

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

Melody Chen

MD, Urology Resident

University Hospitals Cleveland Medical Center

研究点 (1)

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