Back to resultsPROUD Study - Preventing Opioid Use Disorders
Primary Purpose
Anesthesia, Opioid Use
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Guided mindfulness exercises
Self-administered aromatherapy
Baby aspirin
Tylenol/Acetaminophen
Pregabalin
Prednisone
Meloxicam
Prilosec
Tramadol
Voltaren
Zofran
Pepcid
Reglan
Versed
Lidocaine
Propofol
Ancef
Tranexamic Acid (TXA)
Decadron
Bupivacaine hydrochloride
Toradol
Sponsored by
About this trial
This is an interventional treatment trial for Anesthesia focused on measuring Hip replacement, Opioid free, Perioperative period, Team work
Eligibility Criteria
Inclusion Criteria:
Intervention group:
- Prospective study participants undergoing unilateral total hip replacement surgery between the months of February - May 2021
Control:
- Retrospective controls selected from the Emory Healthcare System Clinical Data Warehouse that underwent unilateral total hip replacement surgery between the months of February - May 2020
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.
Sites / Locations
- Emory University Orthopaedic and Spine Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
Prospective cases undergoing non-opioid drug regimen
Retrospective control underwent opioid drug regimen
Professional Staff
Arm Description
Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively
Retrospective controls that underwent unilateral total hip replacement surgery and used opioid drug regimen perioperatively
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04766996
Brief Title
PROUD Study - Preventing Opioid Use Disorders
Official Title
PROUD Study - Preventing Opioid Use Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Loss of surgery team member deemed the study procedures impossible to achieve, and no replacement could be found in a timely manner to complete trial as initially planned.
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
December 27, 2021 (Actual)
Study Completion Date
December 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Opioid Use
Keywords
Hip replacement, Opioid free, Perioperative period, Team work
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Matched Prospective Case with Retrospective Control Study and Staff Survey
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prospective cases undergoing non-opioid drug regimen
Arm Type
Experimental
Arm Description
Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively
Arm Title
Retrospective control underwent opioid drug regimen
Arm Type
No Intervention
Arm Description
Retrospective controls that underwent unilateral total hip replacement surgery and used opioid drug regimen perioperatively
Arm Title
Professional Staff
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Guided mindfulness exercises
Intervention Description
Guided Meditation twice daily
Intervention Type
Other
Intervention Name(s)
Self-administered aromatherapy
Intervention Description
Self-administered aromatherapy every 6 hours and at bedtime
Intervention Type
Drug
Intervention Name(s)
Baby aspirin
Intervention Description
Baby aspirin 81mg: Twice daily for 6 weeks after surgery
Intervention Type
Drug
Intervention Name(s)
Tylenol/Acetaminophen
Intervention Description
Tylenol/Acetaminophen 1000mg: Pre-operative one dose; Every 8 hours for three weeks after surgery
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
Pregabalin 25mg:
Twice a day for two weeks before surgery; Pre-operative 25-100 mg; Twice a day for two weeks after surgery
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Prednisone 5mg: Daily for three weeks after surgery
Intervention Type
Drug
Intervention Name(s)
Meloxicam
Intervention Description
Meloxicam 7.5mg:
Twice a day, with food, for two weeks before surgery; Twice a day, with food, for two weeks after surgery
Intervention Type
Drug
Intervention Name(s)
Prilosec
Intervention Description
Prilosec 20mg:
Daily for two weeks before surgery; Daily for for two weeks after surgery
Intervention Type
Drug
Intervention Name(s)
Tramadol
Intervention Description
Rescue pain medicine Tramadol 50mg up to three times a day as needed will be provided for rescue pain
Intervention Type
Drug
Intervention Name(s)
Voltaren
Intervention Description
Voltaren 1% topical arthritis gel up to 4 times daily pre-operative only
Intervention Type
Drug
Intervention Name(s)
Zofran
Intervention Description
Zofran 4 mg pre-operative
Intervention Type
Drug
Intervention Name(s)
Pepcid
Intervention Description
Pepcid 20 mg pre-operative
Intervention Type
Drug
Intervention Name(s)
Reglan
Intervention Description
Reglan 10 mg pre-operative
Intervention Type
Drug
Intervention Name(s)
Versed
Intervention Description
Versed 2 mg pre-operative
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
Lidocaine (preservative free) height based dosing for subarachnoid block intraoperatively
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Propofol 10-125 mcg/kg/min intraoperative
Intervention Type
Drug
Intervention Name(s)
Ancef
Intervention Description
Ancef 2-3 gm weight-based dosing intraoperative
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid (TXA)
Intervention Description
Tranexamic Acid (TXA) 2 gm intraoperative
Intervention Type
Drug
Intervention Name(s)
Decadron
Intervention Description
Decadron 10 mg intraoperative
Intervention Type
Drug
Intervention Name(s)
Bupivacaine hydrochloride
Intervention Description
Local anaesthetic 0.5% bupivacaine hydrochloride intraoperative
Intervention Type
Drug
Intervention Name(s)
Toradol
Intervention Description
Toradol nonsteroidal anti-inflammatory drug max 30 mg intraoperative
Primary Outcome Measure Information:
Title
Total Post-operative Opioid Requirements With Non-opioid Drug Regimen
Description
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 Outcome Measure Information:
Title
Nebraska Interprofessional Education Attitude Scale (NIPEAS) Score for Professional Staff Arm
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wiltse Nicely, PhD, CRNA
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Orthopaedic and Spine Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in peer reviewed publication(s) will be shared after de-identification.
IPD Sharing Time Frame
Data will be available for sharing beginning 6 months and ending 36 months following article publication.
IPD Sharing Access Criteria
Data will be available for sharing with investigators whose proposed use of the data have been approved by an independent review committee identified for that purpose. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in Emory University's data warehouse but without investigator support other than deposited metadata. Information regarding the Emory Dataverse can be found at: http://sco.library.emory.edu/dataverse/index.html
IPD Sharing URL
http://sco.library.emory.edu/dataverse/index.html
Learn more about this trial
PROUD Study - Preventing Opioid Use Disorders
We'll reach out to this number within 24 hrs