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Clinical Trials/NCT04766996
NCT04766996
Terminated
Phase 4

PROUD Study - Preventing Opioid Use Disorders

Emory University1 site in 1 country57 target enrollmentMay 17, 2021

Overview

Phase
Phase 4
Intervention
Guided mindfulness exercises
Conditions
Anesthesia
Sponsor
Emory University
Enrollment
57
Locations
1
Primary Endpoint
Total Post-operative Opioid Requirements With Non-opioid Drug Regimen
Status
Terminated
Last Updated
2 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 17, 2021
End Date
December 27, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kelly Wiltse Nicely

Assistant Professor

Emory University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • 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.

Arms & Interventions

Prospective cases undergoing non-opioid drug regimen

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

Intervention: Guided mindfulness exercises

Prospective cases undergoing non-opioid drug regimen

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

Intervention: Self-administered aromatherapy

Prospective cases undergoing non-opioid drug regimen

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

Intervention: Baby aspirin

Prospective cases undergoing non-opioid drug regimen

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

Intervention: Tylenol/Acetaminophen

Prospective cases undergoing non-opioid drug regimen

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

Intervention: Pregabalin

Prospective cases undergoing non-opioid drug regimen

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

Intervention: Prednisone

Prospective cases undergoing non-opioid drug regimen

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

Intervention: Meloxicam

Prospective cases undergoing non-opioid drug regimen

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

Intervention: Prilosec

Prospective cases undergoing non-opioid drug regimen

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

Intervention: Tramadol

Prospective cases undergoing non-opioid drug regimen

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

Intervention: Voltaren

Prospective cases undergoing non-opioid drug regimen

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

Intervention: Zofran

Prospective cases undergoing non-opioid drug regimen

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

Intervention: Pepcid

Prospective cases undergoing non-opioid drug regimen

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

Intervention: Reglan

Prospective cases undergoing non-opioid drug regimen

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

Intervention: Versed

Prospective cases undergoing non-opioid drug regimen

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

Intervention: Lidocaine

Prospective cases undergoing non-opioid drug regimen

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

Intervention: Propofol

Prospective cases undergoing non-opioid drug regimen

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

Intervention: Ancef

Prospective cases undergoing non-opioid drug regimen

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

Intervention: Tranexamic Acid (TXA)

Prospective cases undergoing non-opioid drug regimen

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

Intervention: Decadron

Prospective cases undergoing non-opioid drug regimen

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

Intervention: Bupivacaine hydrochloride

Prospective cases undergoing non-opioid drug regimen

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

Intervention: Toradol

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

  • 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))

Study Sites (1)

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