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临床试验/NCT03728517
NCT03728517终止不适用

Comparison of Inpatient Narcotics Use to Outpatient Prescription Narcotics Post-operatively

Indiana University3 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2018年8月23日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
3
主要终点
Understand the factors that impact opioid use for pain management in gynecologic surgery patients after discharge.

研究概览

简要总结

Managing pain in postoperative patients presents challenges in striking a balance between achieving adequate pain control and over-prescribing opioids that have the potential to contribute to the opioid epidemic. There are no clear guidelines informing postoperative opioid prescribing in obstetrics and gynecology.

The primary aim for this study are to better understand the factors that impact opioid use for pain management in gynecologic surgery patient after discharge. The second aim is to develop a model that incorporates individual patient baseline measures (e.g. anxiety, fibromyalgia score, inpatient narcotic consumption) to predict the amount of opioids needed following discharge.

详细描述

Managing pain in postoperative patients presents challenges in striking a balance between achieving adequate pain control and over-prescribing opioids that have the potential to contribute to the opioid epidemic. There are no clear guidelines informing postoperative opioid prescribing in obstetrics and gynecology. A recent study by As-Sanie et al. demonstrated that gynecologists at a large academic medical center prescribe twice the amount of opioids than the average patient uses after hysterectomy.1 Similarly, a study completed at Vanderbilt University Medical Center showed that obstetricians were overprescribing narcotics to patients after cesarean deliveries.2

In addition to rates of opioid prescribing, other factors affect postoperative opioid consumption, including individual patient measures of anxiety, depression, and self-reported pain scores prior to surgery. Preoperative Fibromyalgia symptom scores, STAIT state anxiety scores and NRS pain expectations are independent predictors for morphine consumption following hysterectomy.

There is a pressing need to better understand the factors that impact opioid use in women who undergo gynecologic surgery in order to mitigate the over-use of opioids for pain control upon discharge from the hospital.

Aims:

  1. Understand the factors that impact opioid use for pain management in gynecologic surgery patients after discharge.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 18 years old or older
  • Undergoing vaginal, laparoscopic or robotic gynecologic surgery requiring observation or inpatient stay overnight
  • Agree to receiving contact from research staff for follow up
  • Can provide two telephone numbers or a telephone number and email address

排除标准

  • Unable to provide informed consent
  • Intolerance/allergy to more than two narcotic medications
  • Allergy/contraindication to non-steroidal anti-inflammatory drugs (NSAIDs)
  • Has a diagnosed gynecologic malignancy other than Grade 1 endometrial cancer
  • Current opioid use on a regular basis (more than twice per week)
  • Illicit drug-use within the past 30 days

结局指标

主要结局

Understand the factors that impact opioid use for pain management in gynecologic surgery patients after discharge.

时间窗: 1 year

1. Is opioid consumption during the immediate postoperative recovery phase associated with consumption after discharge? 2. Are variables that are known to be associated with opioid consumption, also associated with opioid consumption after discharge? 3. Are there factors which we can use to predict opioid consumption in postoperative patients?

次要结局

  • Develop a model(1 year)

研究者

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

Insiyyah Patanwala

Principle Investigator

Indiana University

研究点 (3)

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