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临床试验/NCT05078398
NCT05078398已完成不适用

Postoperative Opt-In Narcotics Treatment in Breast

University of California, Los Angeles4 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
109
试验地点
4
主要终点
Daily peak pain scores on an 11-point numeric rating scale [0-10, with 0 indicating no pain and 10 indicating worst pain possible]

研究概览

简要总结

In a recent study, researchers let patients choose what medications to go home with after endocrine surgery. This has not been done in outpatient breast surgery, though several institutions have moved towards avoiding opioids altogether after breast surgery. These institutions only prescribed rescue opioids upon request.

The aim of this study is to compare a similar "opt-in" protocol for narcotics to usual care (where patients are routinely discharged with opioids) for outpatient breast surgery.

This study will be designed as a randomized, controlled trial. When adult patients consent for outpatient breast surgery, the patients will be asked to participate in the study. Patients who are currently using narcotics would be excluded. The investigators would then randomize participants to the "opt-in" protocol versus being provided with a standard opioid prescription after surgery. Patients in the opt-in protocol will be recommended a pain treatment regimen with over-the-counter medications, acetaminophen or ibuprofen. These patients will be reassured that if their pain is uncontrolled after discharge, a narcotic prescription will be called in to their pharmacy if requested.

The investigators will assess patient pain scores and medication use in the recovery area using the electronic medical record. The investigators will collect data on patient pain scores and medication use after discharge on a daily basis via phone call or electronically transmitted survey. The investigators will also evaluate patients at the time of their follow-up visits. Any patient phone calls will be routed to study personnel who will fill narcotic prescription requests if requested. Finally, among patients who do receive an opioid prescription, the investigators will track their opioid consumption.

详细描述

Due to the current opioid epidemic, there has been increased focus on the prescribing patterns of physicians and greater incentive to reduce the amount of narcotic pain medication prescribed.

A recent publication in Journal of American Medical Association Surgery conducted by researchers from the same institution found that giving patients the option of choosing to receive a narcotic prescription or not following endocrine surgery significantly reduced opioid prescriptions and waste without increased pain or worse quality of life. No patients called in to request narcotic pain medication after discharge.

Significance:

Given the current health care and political climate, there has been increasing focus on reducing the amount of narcotics prescribed by health care providers. Based on the results of the above cited study, the investigators believe implementing an opt-in program at University of California at Los Angeles will also significantly decrease the amount of opioids prescribed for postoperative pain following outpatient breast surgery as well.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Undergoing outpatient breast surgery (less than 24 hour stay)
  • Understands written English

排除标准

  • Current ongoing opioid use
  • Increased complexity of surgery requiring longer hospital stay

结局指标

主要结局

Daily peak pain scores on an 11-point numeric rating scale [0-10, with 0 indicating no pain and 10 indicating worst pain possible]

时间窗: Postoperative day 0-7

Daily peak pain

Number of opioid pills dispensed

时间窗: Postoperative day 0-7

Total number of pills, (also to be expressed in morphine equivalents) dispensed on day of surgery as well through the immediate post operative period if refills or a rescue prescription were requested

次要结局

  • Physical and Mental Health Summary Score from Patient-Reported Outcomes Measurement Information System (PROMIS) Survey (T-score, mean is 50 and 10 is standard deviation)(Baseline and postoperative day 7)
  • Amount of opioid pills consumed(Postoperative day 0-7)

研究者

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

James Wu, MD

Assistant Professor

University of California, Los Angeles

研究点 (4)

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