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临床试验/NCT03173131
NCT03173131Unknown不适用

Opioid Consumption After Orthopaedic Surgery: Prospective Randomized Trial on the Effects of Pre-Operative Counseling

Thomas Jefferson University1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2017年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
280
试验地点
1
主要终点
Post operative opioid consumption

研究概览

简要总结

This is a randomized controlled study that will involve fellowship-trained board certified orthopaedic surgeons in four different subspecialties (hand surgery, sports surgery, shoulder and elbow surgery, and foot and ankle surgery) within our practice group. Consenting patients will be randomized to the treatment group (receiving preoperative counseling) or to the control group (no preoperative counseling). The control limb will provide us with information regarding average opioid consumption following common outpatient orthopedic procedures, and the study limb will allow us to evaluate the effect of the pre-operative opioid counseling.

详细描述

Over the past two decades in the United States, the opioid epidemic has escalated at a startling rate and prescription opioids are a large contributor to this problem. Studies show that there is an excessive amount of opioids being prescribed for orthopedic procedures. An accurate understanding of opioid consumption following common outpatient orthopedic surgery is imperative in order to treat pain appropriately relative to the surgery being performed without leading to excess narcotic prescribing.

The purpose of the study is threefold: to better understand typical opioid consumption following common outpatient orthopedic surgeries, to generate prescribing guidelines to optimize opioid prescribing, and to understand the effect of pre-operative opioid counseling on opioid consumption following these procedures.

This is a prospective randomized controlled study that will involve eight fellowship-trained board certified orthopaedic surgeons in four different subspecialties (hand surgery, sports surgery, shoulder and elbow surgery, and foot and ankle surgery). Consenting patients will be randomized to the treatment group (receiving preoperative counseling) or to the control group (no preoperative counseling). The control limb will provide us with information regarding average opioid consumption following common outpatient orthopedic procedures, and the study limb will allow us to evaluate the effect of the pre-operative counseling.

Basic demographic and surgical data will be collected. Primary outcomes will be assessed at the post-operative visit. These include the total number of opioid pills consumed, average daily pain scores, and adverse effects. Secondary outcomes include the number of days the medication was used, medication refill requests, and patient satisfaction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Care Provider, Investigator)

入排标准

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

入选标准

  • •Patients indicated to undergo outpatient orthopedic surgery in one of the four areas included in the study (hand surgery, sports surgery, shoulder and elbow surgery, and foot and ankle surgery).
  • •Age eligibility is > 18 years of age.

排除标准

  • •Inpatient procedures.
  • •Pediatric patients (age < 18 years).
  • •Known allergy to narcotic medication.
  • •Pregnant female patients.
  • •Non-English speaking patients
  • •History of chronic pain and/or narcotic use preoperatively.

研究组 & 干预措施

Opioid counseling group

Experimental

Counseling provided to patients prior to surgery regarding opioid usage, side effect, long term effect and risks of opioids.

干预措施: Pre-operative opioid counseling (Behavioral)

No Counseling

No Intervention

No preoperative counseling will be provided to this group. Standard medication information will be provided only.

结局指标

主要结局

Post operative opioid consumption

时间窗: 3 months

The primary outcome measure will be post operative opioid consumption.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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