PROUD Study - Preventing Opioid Use Disorders

Sponsor

Emory University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04766996

Collaborator

(none)

170

Enrollment

Location

Arms

18.5

Anticipated Duration (Months)

9.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anesthesia Opioid Use	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	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

170 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Matched Prospective Case with Retrospective Control Study and Staff SurveyMatched Prospective Case with Retrospective Control Study and Staff Survey

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

PROUD Study - Preventing Opioid Use Disorders

Actual Study Start Date :

May 17, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prospective cases undergoing non-opioid drug regimen Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively	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 Drug: Tylenol/Acetaminophen Tylenol/Acetaminophen 1000mg: Pre-operative one dose; Every 8 hours for three weeks after surgery Drug: Pregabalin Pregabalin 25mg: Twice a day for two weeks before surgery; Pre-operative 25-100 mg; Twice a day for two weeks after surgery Drug: Prednisone Prednisone 5mg: Daily for three weeks after surgery Drug: Meloxicam Meloxicam 7.5mg: Twice a day, with food, for two weeks before surgery; Twice a day, with food, for two weeks after surgery Drug: Prilosec Prilosec 20mg: Daily for two weeks before surgery; Daily for for two weeks after surgery Drug: Tramadol Rescue pain medicine Tramadol 50mg up to three times a day as needed will be provided for rescue pain Drug: Voltaren Voltaren 1% topical arthritis gel up to 4 times daily pre-operative only Drug: Zofran Zofran 4 mg pre-operative Drug: Pepcid Pepcid 20 mg pre-operative Drug: Reglan Reglan 10 mg pre-operative Drug: Versed Versed 2 mg pre-operative Drug: Lidocaine Lidocaine (preservative free) height based dosing for subarachnoid block intraoperatively Drug: Propofol Propofol 10-125 mcg/kg/min intraoperative Drug: Ancef Ancef 2-3 gm weight-based dosing intraoperative Drug: Tranexamic Acid (TXA) Tranexamic Acid (TXA) 2 gm intraoperative Drug: Decadron Decadron 10 mg intraoperative Drug: Bupivacaine hydrochloride Local anaesthetic 0.5% bupivacaine hydrochloride intraoperative Drug: Toradol Toradol nonsteroidal anti-inflammatory drug max 30 mg intraoperative
No Intervention: Retrospective control underwent opioid drug regimen Retrospective controls that underwent unilateral total hip replacement surgery and used opioid drug regimen perioperatively
No Intervention: Professional Staff 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.

Arm

Intervention/Treatment

Experimental: Prospective cases undergoing non-opioid drug regimen

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

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

Drug: Tylenol/Acetaminophen

Tylenol/Acetaminophen 1000mg: Pre-operative one dose; Every 8 hours for three weeks after surgery

Drug: Pregabalin

Pregabalin 25mg: Twice a day for two weeks before surgery; Pre-operative 25-100 mg; Twice a day for two weeks after surgery

Drug: Prednisone

Prednisone 5mg: Daily for three weeks after surgery

Drug: Meloxicam

Meloxicam 7.5mg: Twice a day, with food, for two weeks before surgery; Twice a day, with food, for two weeks after surgery

Drug: Prilosec

Prilosec 20mg: Daily for two weeks before surgery; Daily for for two weeks after surgery

Drug: Tramadol

Rescue pain medicine Tramadol 50mg up to three times a day as needed will be provided for rescue pain

Drug: Voltaren

Voltaren 1% topical arthritis gel up to 4 times daily pre-operative only

Drug: Zofran

Zofran 4 mg pre-operative

Drug: Pepcid

Pepcid 20 mg pre-operative

Drug: Reglan

Reglan 10 mg pre-operative

Drug: Versed

Versed 2 mg pre-operative

Drug: Lidocaine

Lidocaine (preservative free) height based dosing for subarachnoid block intraoperatively

Drug: Propofol

Propofol 10-125 mcg/kg/min intraoperative

Drug: Ancef

Ancef 2-3 gm weight-based dosing intraoperative

Drug: Tranexamic Acid (TXA)

Tranexamic Acid (TXA) 2 gm intraoperative

Drug: Decadron

Decadron 10 mg intraoperative

Drug: Bupivacaine hydrochloride

Local anaesthetic 0.5% bupivacaine hydrochloride intraoperative

Drug: Toradol

Toradol nonsteroidal anti-inflammatory drug max 30 mg intraoperative

No Intervention: Retrospective control underwent opioid drug regimen

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

No Intervention: Professional Staff

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.

Outcome Measures

Primary Outcome Measures

Total post-operative opioid requirements [Up to 5 weeks]
Total post-operative opioid requirements (opioid dose) will be calculated

Secondary Outcome Measures

Change in the Nebraska Interprofessional Education Attitude Scale (NIPEAS) score [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 survey will be provided to all consented perioperative suite professional staff. The NIPEAS is a 19-item questionnaire assessing attitudes related to interprofessional collaboration. The items are rated from 1=Strongly Agree to 5=Strongly Disagree.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.