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临床试验/NCT04169113
NCT04169113已完成不适用

How Many Opiates Should be Prescribed for Pain in Patients Undergoing Hip Arthroscopy?

Northwestern University2 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2018年6月12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
111
试验地点
2
主要终点
Number of Participants Reporting Side Effects

研究概览

简要总结

The purpose of the study is to determine if opiates are required to achieve appropriate analgesia after hip arthroscopy in outpatient surgery. The investigators hypothesize that patients are frequently prescribed more opiates than are needed after surgery, resulting in excess medications that are at risk for misuse, diversion and contribution to the opioid epidemic

详细描述

Perioperative pain management is an important aspect of quality patient care. Opioid pain medications are increasingly being used for pain control, with the United States writing over 250 million prescriptions for painkillers per year. Increased usage has led to unintended negative consequences for individuals and society. It is estimated that 46 people die each day from an overdose of prescription painkillers, and individual use can lead to the development of tolerance and worse treatment outcomes. Further issues arise when opioids are misused, it is estimated that nontherapeutic use has increased three fold in recent years. In the United States alone in 2006 the estimated total cost of opioid prescription misuse was $53.4 billion, of which $42 billion was attributed to lost productivity, $8.2 billion to criminal justice cost and the remainder drug abuse treatment and medical complications. The federal government has recognized this epidemic and raised a call for clinicians to more responsibly prescribe opiate pain medications

Opiate use has increased in recent years, from 2000-2010 the use of opiates in office based visits nearly doubled from 11.3% to 19.6% whereas there was no change in the prescribing of non-opioid pharmacotherapies. Further, when specifically looking at new musculoskeletal pain visits, one half resulted in pharmacologic treatment, with the prescribing of non-opioid pharmacotherapies decreasing from 38% to 29% from 2000 to 2010, respectively. The clinical use of opioids for post-operative pain control has also been linked to the opioid epidemic and risk of future abuse. Legitimate opioid use before high school graduation is independently associated with a 33% increased risk of future misuse after high school.

It has been estimated that orthopedic surgeons prescribe 7.7% of all opioids in the United States.Special attention needs to be paid to the amount of opioid pain medications orthopedic surgeons prescribe to patients after ambulatory surgery, there is considerable variability among surgeon and procedure in regards to the amount of opioids to prescribe with many patients left with excess unused medication .An analysis of 250 patients undergoing outpatient upper extremity surgery found that on average patients consumed 10 opioid pills, with 19 pills left over and a total of 4,639 pills going unused in the cohort. Leftover prescription opioids are at risk for diversion to family and friends for nonmedical use. Further studies are needed to quantify the amount of opioids to prescribe for specific orthopedic procedures to limit excess narcotic use, misuse, diversion and contribution to the opioid epidemic.

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 (Care Provider)

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients presenting to Northwestern Memorial Hospital (NMH) or to a Northwestern orthopaedic surgery faculty member's clinic undergoing hip arthroscopy
  • 18 years old or greater
  • Ability to read and speak English

排除标准

  • Revision surgery
  • Oncologic etiology
  • Arthroscopic hip surgery that involves procedures other than labral repair, acetabuloplasty, CAM-plasty, IT band windowing, Iliopsoas lengthening
  • Patients with a current indication of narcotic use
  • Individuals unable to provide informed consent:
  • Prisoners
  • Pregnant women
  • Minors/Individuals under 18 years of age

结局指标

主要结局

Number of Participants Reporting Side Effects

时间窗: 21 days postoperatively

As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting

Opiates Taken

时间窗: 21 days post-operative

Number of prescribed narcotic medication tablets taken in the preceding time period

Numeric Pain Rating Scale (NPRS) Pain Scores

时间窗: 21 days

minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient

Opiates Remaining

时间窗: 21 days post-operative

Number of prescribed narcotic medication tablets remaining from initial amount prescribed

Date of Last Opiate Taken

时间窗: 21 days post-operative

Days following surgery that the most recent dose of narcotic medication was taken

次要结局

未报告次要终点

研究者

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

Vehniah Tjong

Assistant Professor of Orthopaedic Surgery

Northwestern University

研究点 (2)

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