NCT05571072已完成不适用
Opioid Use After Urogynecologic Procedures: Using a Predictive Calculator
David Sheyn2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2023年1月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Change in pain scores measured by team-created pain questionnaires
研究概览
简要总结
The purpose of this study is to determine if the investigators can precisely predict how much pain medication the subjects will need after surgery using a special calculator that was developed for this purpose.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-89
- •Able to provide informed consent
- •Patients undergoing any of below urogynecologic procedures
- •Included urogynecologic procedures:
- •Sacrocolpopexy - robotic or laparoscopic
- •With or without hysterectomy
- •With or without salpingo-oophorectomy
- •With or without anterior colporrhaphy
- •With or without posterior colporrhaphy/perineorrhaphy
- •With or without midurethral sling
- •Sacrospinous ligament fixation
- •With or without hysterectomy
- •With or without salpingo-oophorectomy
- •With or without anterior colporrhaphy
- •With or without posterior colporrhaphy/perineorrhaphy
- •With or without midurethral sling
- •Uterosacral ligament suspension - robotic, laparoscopic, or vaginal
- •With or without hysterectomy
- •With or without salpingo-oophorectomy
- •With or without anterior colporrhaphy
- •With or without posterior colporrhaphy/perineorrhaphy
- •With or without midurethral sling
- •Colpocleisis
- •Lefort colpocleisis
- •Complete colpectomy with colpocleisis
- •Isolated anterior and/or posterior colporrhaphy
排除标准
- •Non-English speakers
- •pre-operative diagnosis of cancer
- •scheduled for any concurrent non-urogynecologic procedure (ex: abdominoplasty)
- •<18 years or >89 years of age
- •unable to provide informed consent
结局指标
主要结局
Change in pain scores measured by team-created pain questionnaires
时间窗: baseline, 1 week post-op, 2 weeks post-op
Pain questionnaire is a 2 question survey that ask patients to rate pain on scale of 0 (no pain) to 10 (worst pain) immediately post-op and current. Baseline will be calculated by asking patient's expected post-op pain score.
次要结局
- Change in satisfaction scores measured by team-created questionnaire(1 week post-op, 2 weeks post-op)
- Change in number of opioid tablets remaining measured by team-created questionnaire(1 week post-op, 2 weeks post-op)
研究者
David Sheyn
Associate Professor of Urology
University Hospitals Cleveland Medical Center
研究点 (2)
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