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临床试验/NCT06532708
NCT06532708招募中不适用

Prospective Study of Opioid Prescribing Practices in Laparoscopic Gynecologic Surgery

University of Tennessee2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年7月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
12
试验地点
2
主要终点
Number of pills used

研究概览

简要总结

The purpose of this study is to compare opioid prescribing practices by either routine provider prescribing practices, or with the use of a calculator, i.e., the Opioid Calculator, published by the University of Michigan (www.opioidcalculator.org), with the intent of decreasing the number of pills.

详细描述

The intent of this study is to validate the use of the Opioid Calculator, published at University of Michigan (www.opioidcalculator.org), which takes several variables into account, including age, risk factors (history of depression, alcohol abuse, others) to determine in a more scientific way the number of pills sufficient to prescribe. The sample size was determined by the number of routine post-op laparoscopic patients seen in our practice. The estimated necessary sample size is 6 participants per group (12 total). Patients will be randomized using 3 block groups of size 4 each. Patients will be approached at in clinic at the time they are consenting to laparoscopic hysterectomy and will be counseled about postoperative pain medication management. Randomization to either standard practice or calculator will be performed using computer-generated, permuted blocks of 4 participants. Sealed randomization envelopes will be opened for each subject on the day of surgery, after anesthesia is initiated. The study will be singled-blinded to the participant. Patients will be contacted on day 2 and day 7 to inquire where they are on the Visual Analog Scale (VAS) and how many pills they have taken. Two weeks after surgery patients will be seen in office for VAS and requested to bring unused pills for accounting purposes.

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 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 18 to 80
  • Undergoing planned laparoscopic hysterectomy as a day surgery procedure

排除标准

  • Women aged 18 to 80
  • Undergoing a non-laparoscopic unplanned surgical procedure
  • Patients with a history of opioid use disorder or current opioid use disorder

结局指标

主要结局

Number of pills used

时间窗: Within 1 week following surgery

All participants will be contacted on postoperative days 2 and 7 to inquire how many pills they have taken

次要结局

  • Postoperative pain(Within 2 weeks following surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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