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临床试验/NCT04766996
NCT04766996终止4 期

PROUD Study - Preventing Opioid Use Disorders

Emory University1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2021年5月17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
终止
入组人数
57
试验地点
1
主要终点
Total Post-operative Opioid Requirements With Non-opioid Drug Regimen

研究概览

简要总结

The objective of this study is to pilot an opioid free anesthetic protocol for patients undergoing total hip replacement.

详细描述

The objective of this study is to pilot an opioid free anesthetic protocol for patients undergoing total hip replacement. The study team identified alternative pharmacologic methods to block pain pathways to reduce or even eliminate the need for opioids in the intra- and postoperative periods, with the goal of decreasing or eliminating exposure to opioids. A secondary objective is to assess two core competencies for interprofessional collaborative practice (Interprofessional Communication and Teams; and Teamwork) within the interprofessional care team implementing the opioid free protocol.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • 未提供

排除标准

  • Participants that do not speak English will not be eligible for participation in the study.
  • Individuals less than 18 years of age will not be included for participation in the study.
  • Individuals with cognitive impairment or the inability to provide informed consent will not be included in the study.

研究组 & 干预措施

Prospective cases undergoing non-opioid drug regimen

Experimental

Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively

干预措施: Guided mindfulness exercises (Behavioral)

Prospective cases undergoing non-opioid drug regimen

Experimental

Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively

干预措施: Self-administered aromatherapy (Other)

Prospective cases undergoing non-opioid drug regimen

Experimental

Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively

干预措施: Baby aspirin (Drug)

Prospective cases undergoing non-opioid drug regimen

Experimental

Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively

干预措施: Tylenol/Acetaminophen (Drug)

Prospective cases undergoing non-opioid drug regimen

Experimental

Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively

干预措施: Pregabalin (Drug)

Prospective cases undergoing non-opioid drug regimen

Experimental

Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively

干预措施: Prednisone (Drug)

Prospective cases undergoing non-opioid drug regimen

Experimental

Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively

干预措施: Meloxicam (Drug)

Prospective cases undergoing non-opioid drug regimen

Experimental

Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively

干预措施: Prilosec (Drug)

Prospective cases undergoing non-opioid drug regimen

Experimental

Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively

干预措施: Tramadol (Drug)

Prospective cases undergoing non-opioid drug regimen

Experimental

Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively

干预措施: Voltaren (Drug)

Prospective cases undergoing non-opioid drug regimen

Experimental

Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively

干预措施: Zofran (Drug)

Prospective cases undergoing non-opioid drug regimen

Experimental

Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively

干预措施: Pepcid (Drug)

Prospective cases undergoing non-opioid drug regimen

Experimental

Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively

干预措施: Reglan (Drug)

Prospective cases undergoing non-opioid drug regimen

Experimental

Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively

干预措施: Versed (Drug)

Prospective cases undergoing non-opioid drug regimen

Experimental

Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively

干预措施: Lidocaine (Drug)

Prospective cases undergoing non-opioid drug regimen

Experimental

Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively

干预措施: Propofol (Drug)

Prospective cases undergoing non-opioid drug regimen

Experimental

Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively

干预措施: Ancef (Drug)

Prospective cases undergoing non-opioid drug regimen

Experimental

Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively

干预措施: Tranexamic Acid (TXA) (Drug)

Prospective cases undergoing non-opioid drug regimen

Experimental

Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively

干预措施: Decadron (Drug)

Prospective cases undergoing non-opioid drug regimen

Experimental

Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively

干预措施: Bupivacaine hydrochloride (Drug)

Prospective cases undergoing non-opioid drug regimen

Experimental

Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively

干预措施: Toradol (Drug)

结局指标

主要结局

Total Post-operative Opioid Requirements With Non-opioid Drug Regimen

时间窗: Up to 5 weeks

Total post-operative opioid requirements (opioid dose) were calculated for participants receiving the non-opioid drug regimen, among participants who required post-operative opioid medication.

次要结局

  • Nebraska Interprofessional Education Attitude Scale (NIPEAS) Score for Professional Staff Arm(Prior to protocol implementation (baseline), halfway through the recruitment period (2 months) and after the last participant has been discharged from the hospital (4 months))

研究者

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

Kelly Wiltse Nicely

Assistant Professor

Emory University

研究点 (1)

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