PROUD Study - Preventing Opioid Use Disorders

Anesthesia Clinical Trial

Official title:

PROUD Study - Preventing Opioid Use Disorders

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04766996
• Other study ID #: STUDY00002021
• Status: Terminated
• Phase: Phase 4
• Start date: May 17, 2021
• Est. completion date: December 27, 2021

Study information

• Verified date: June 2023
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Terminated
• Enrollment: 57
• Est. completion date: December 27, 2021
• Est. primary completion date: December 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Opioid Use
• Opioid-Related Disorders

Intervention

Behavioral:
• Guided mindfulness exercises
Guided Meditation twice daily

Other:
• Self-administered aromatherapy
Self-administered aromatherapy every 6 hours and at bedtime

Drug:
• Baby aspirin
Baby aspirin 81mg: Twice daily for 6 weeks after surgery
• Tylenol/Acetaminophen
Tylenol/Acetaminophen 1000mg: Pre-operative one dose; Every 8 hours for three weeks after surgery
• Pregabalin
Pregabalin 25mg: Twice a day for two weeks before surgery; Pre-operative 25-100 mg; Twice a day for two weeks after surgery
• Prednisone
Prednisone 5mg: Daily for three weeks after surgery
• Meloxicam
Meloxicam 7.5mg: Twice a day, with food, for two weeks before surgery; Twice a day, with food, for two weeks after surgery
• Prilosec
Prilosec 20mg: Daily for two weeks before surgery; Daily for for two weeks after surgery
• Tramadol
Rescue pain medicine Tramadol 50mg up to three times a day as needed will be provided for rescue pain
• Voltaren
Voltaren 1% topical arthritis gel up to 4 times daily pre-operative only
• Zofran
Zofran 4 mg pre-operative
• Pepcid
Pepcid 20 mg pre-operative
• Reglan
Reglan 10 mg pre-operative
• Versed
Versed 2 mg pre-operative
• Lidocaine
Lidocaine (preservative free) height based dosing for subarachnoid block intraoperatively
• Propofol
Propofol 10-125 mcg/kg/min intraoperative
• Ancef
Ancef 2-3 gm weight-based dosing intraoperative
• Tranexamic Acid (TXA)
Tranexamic Acid (TXA) 2 gm intraoperative
• Decadron
Decadron 10 mg intraoperative
• Bupivacaine hydrochloride
Local anaesthetic 0.5% bupivacaine hydrochloride intraoperative
• Toradol
Toradol nonsteroidal anti-inflammatory drug max 30 mg intraoperative

Locations

Country	Name	City	State
United States	Emory University Orthopaedic and Spine Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 5 weeks
Secondary	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.	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)