A Randomized Trial of Liberal vs. Restricted Post-discharge Opioid Prescribing Following Midurethral Sling
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Pain score on postoperative day 1
研究概览
简要总结
The specific objective of this proposal is to evaluate pain and opioid use following a midurethral sling (MUS) under two different opioid prescribing schemes. The central hypothesis is that, in spite of the fact that opioids are often routinely prescribed by many surgeons following this procedure, most patients do not require them for pain control, and patients who are not prescribed postoperative will have similar pain scores and pain control satisfaction compared with patients who are routinely prescribed a standard amount of opioids for postoperative pain control.
详细描述
The investigators have 3 specific aims:
Specific Aim #1: Compare patients' postoperative pain experience and satisfaction with pain control using two different opioid prescribing schemes.
The investigators' working hypothesis is that postoperative pain control and satisfaction will be non-inferior between patients routinely prescribed opioids vs. those not routinely prescribed opioids prior to surgery.
Participants will be asked to complete a pain diary and assessment of their pain control satisfaction postoperatively. Pain control will be assessed by Likert scores (0-10) and satisfaction with pain control will be queried using an integer scale of 0-5 using REDCap or paper survey for the first 7 days postoperatively.
Specific Aim #2: Examine the opioid use of patients following midurethral sling.
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
- Female
- 接受健康志愿者
- 是
入选标准
- •Scheduled to undergo isolated midurethral sling after evaluation and discussion with surgeon
- •Consent to participate in this study
排除标准
- •Pregnant or breast feeding
- •Cognitively impaired women
- •Pre-existing diagnosis of opioid use disorder
- •Patients with chronic daily opioid use
- •Prisoners
- •Non-English speaking or inability to read, as a result of the need to read and report daily results in English
- •Allergy to oral opioids used in this study (oxycodone)
- •Significant contraindications (allergy, severe hepatic or renal compromise, or other medical conditions deemed by surgeon) to the use of both NSAIDs (ibuprofen, naproxen) and acetaminophen
结局指标
主要结局
Pain score on postoperative day 1
时间窗: postoperative day 1
Numeric score of pain at end of day (0-10 with 10 being the worst imaginable pain)
次要结局
- Satisfaction with pain control(postoperative day 7 daily scores will be assessed)
- The number of opioid pills used by those to whom they were prescribed(postoperative day 7 daily scores will be assessed)
- Calls for new opioid prescriptions or refills postoperatively(postoperative day 7 daily outcome will be assessed)
- Psychometric survey and clinical/demographic factors associated with opioid use postoperatively(Upon enrollment)
研究者
Jaime Long
Assistant Professor, Department of Obstetrics and Gynecology
Milton S. Hershey Medical Center