PROUD Study - Preventing Opioid Use Disorders

Emory University

Status and phase: Terminated; Phase 4

Conditions: Opioid Use; Anesthesia

Treatments: Drug: Tramadol; Behavioral: Guided mindfulness exercises; Drug: Ancef; Drug: Prednisone; Drug: Tranexamic Acid (TXA); Drug: Toradol; Drug: Zofran; Other: Self-administered aromatherapy; Drug: Versed; Drug: Voltaren; Drug: Lidocaine; Drug: Pregabalin; Drug: Prilosec; Drug: Bupivacaine hydrochloride; Drug: Propofol; Drug: Pepcid; Drug: Decadron; Drug: Reglan; Drug: Meloxicam; Drug: Tylenol/Acetaminophen; Drug: Baby aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT04766996

STUDY00002021

Details and patient eligibility

About

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

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Intervention group:

• Prospective study participants undergoing unilateral total hip replacement surgery between the months of February through May, 2021

Inclusion Criteria Control:

• Retrospective controls selected from the Emory Healthcare System Clinical Data Warehouse that underwent unilateral total hip replacement surgery between the months of February through May, 2020

Inclusion Criteria Professional Staff:

• All staff that participate in the implementation of the opioid free surgical protocol.

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 3 patient groups

Prospective cases undergoing non-opioid drug regimen

Experimental group

Description:

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

Treatment:

Drug: Voltaren

Drug: Versed

Drug: Toradol

Drug: Zofran

Drug: Prednisone

Other: Self-administered aromatherapy

Drug: Bupivacaine hydrochloride

Drug: Decadron

Drug: Pregabalin

Drug: Prilosec

Drug: Lidocaine

Drug: Propofol

Drug: Pepcid

Drug: Meloxicam

Drug: Reglan

Drug: Tylenol/Acetaminophen

Drug: Baby aspirin

Drug: Tranexamic Acid (TXA)

Drug: Ancef

Drug: Tramadol

Behavioral: Guided mindfulness exercises

Retrospective control underwent opioid drug regimen

No Intervention group

Description:

Retrospective controls that underwent unilateral total hip replacement surgery and used opioid drug regimen perioperatively

Professional Staff

No Intervention group

Description:

Staff that participate in the implementation of the opioid free surgical protocol will be completing team assessment surveys seeking their opinion about interprofessional teamwork and communication.