PROUD Study - Preventing Opioid Use Disorders

Phase 4

Terminated

Conditions: Opioid Use
Anesthesia

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

Registration Number: NCT04766996

Lead Sponsor: Emory University

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 57

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prospective cases undergoing non-opioid drug regimen	Ancef	Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively
Prospective cases undergoing non-opioid drug regimen	Versed	Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively
Prospective cases undergoing non-opioid drug regimen	Guided mindfulness exercises	Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively
Prospective cases undergoing non-opioid drug regimen	Self-administered aromatherapy	Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively
Prospective cases undergoing non-opioid drug regimen	Tylenol/Acetaminophen	Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively
Prospective cases undergoing non-opioid drug regimen	Prilosec	Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively
Prospective cases undergoing non-opioid drug regimen	Baby aspirin	Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively
Prospective cases undergoing non-opioid drug regimen	Tranexamic Acid (TXA)	Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively
Prospective cases undergoing non-opioid drug regimen	Pregabalin	Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively
Prospective cases undergoing non-opioid drug regimen	Prednisone	Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively
Prospective cases undergoing non-opioid drug regimen	Voltaren	Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively
Prospective cases undergoing non-opioid drug regimen	Tramadol	Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively
Prospective cases undergoing non-opioid drug regimen	Meloxicam	Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively
Prospective cases undergoing non-opioid drug regimen	Pepcid	Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively
Prospective cases undergoing non-opioid drug regimen	Zofran	Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively
Prospective cases undergoing non-opioid drug regimen	Decadron	Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively
Prospective cases undergoing non-opioid drug regimen	Reglan	Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively
Prospective cases undergoing non-opioid drug regimen	Lidocaine	Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively
Prospective cases undergoing non-opioid drug regimen	Propofol	Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively
Prospective cases undergoing non-opioid drug regimen	Bupivacaine hydrochloride	Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively
Prospective cases undergoing non-opioid drug regimen	Toradol	Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively

Primary Outcome Measures

Name	Time	Method
Total Post-operative Opioid Requirements With Non-opioid Drug Regimen	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 Outcome Measures

Name	Time	Method
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)	The Nebraska Interprofessional Education Attitude Scale (NIPEAS) was developed to measure the attitudes of pre-clinical learners to practicing health professionals. The NIPEAS is a 19-item questionnaire assessing attitudes related to interprofessional collaboration. Responses were given using a 5-point Likert scale where 1 = Strongly Disagree to 5 = Strongly Agree. The total score is the average of the average scores for each item and ranges from 1 to 5. A higher total score indicates increased positive perceptions toward interprofessional collaboration.