PROUD Study - Preventing Opioid Use Disorders

Phase 4TerminatedNCT04766996

Emory University57 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anesthesia Opioid Use

Interventions

Guided mindfulness exercisesBEHAVIORAL

Guided Meditation twice daily

Self-administered aromatherapyOTHER

Self-administered aromatherapy every 6 hours and at bedtime

Baby aspirinDRUG

Baby aspirin 81mg: Twice daily for 6 weeks after surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Emory University Orthopaedic and Spine Hospital

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

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

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.

Time frame: Up to 5 weeks

Secondary Outcomes

Nebraska Interprofessional Education Attitude Scale (NIPEAS) Score for Professional Staff Arm

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.

Time frame: 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)

Data from ClinicalTrials.gov

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