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临床试验/NCT05327777
NCT05327777已完成4 期

Toward Zero Prescribed Opioids for Outpatient General Surgery Procedures: a Prospective Cohort Trial

Thomas Jefferson University1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2019年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
129
试验地点
1
主要终点
Morphine Milligram Equivalents Taken by Participants

研究概览

简要总结

Investigators have created an opioid reduction "package" which includes patient education, non-narcotic pain control instructions, and limited (or no) opioid pain prescriptions provided at discharge in an attempt to reduce the number of opioid consumption after outpatient general surgery.

详细描述

Between November 2019 and July 2021, patients undergoing elective inguinal hernia repair (IHR) or cholecystectomy were enrolled in the study. Patients were divided into three cohorts: Control, opioid sparing (OS), or zero-opioid (ZO). Control patients did not have any intervention; OS patients had an opioid reduction intervention protocol applied (patient education and perioperative multimodal analgesia) and were provided an opioid prescription at discharge; the ZO had the same protocol, however patients were not provided opioid prescriptions at discharge. Two weeks after discharge patients were interviewed to record opioid consumption, pain scores, and level of satisfaction since discharge.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Opioid naïve patients
  • Age > 18
  • Being scheduled for an outpatient elective inguinal hernia repair or cholecystectomy

排除标准

  • Urgent/emergent status
  • Previous cholecystostomy tube placement

研究组 & 干预措施

Opioid Sparing

Experimental

Providers required to prescribe 10 narcotic pills only

干预措施: Oxycodone (Drug)

Zero Opioid

Experimental

No narcotic prescription is provided to patient at discharge

干预措施: Zero Opioid Protocol (Behavioral)

结局指标

主要结局

Morphine Milligram Equivalents Taken by Participants

时间窗: 14 days

Patients will be interviewed fourteen days after procedure and asked how many opioid pills they have taken since being discharged form the hospitals

次要结局

  • Satisfaction Scores Ranging From 1 - 10(14 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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