PROUD Study - Preventing Opioid Use Disorders

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

Detailed Description
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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.

Official Title
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PROUD Study - Preventing Opioid Use Disorders

Conditions
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Anesthesia, Opioid Use

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Matched Prospective Case with Retrospective Control Study and Staff Survey
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prospective cases undergoing non-opioid drug regimen<br>Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively | Behavioral: Guided mindfulness exercises<br>* Guided Meditation twice daily<br>Other: Self-administered aromatherapy<br>* Self-administered aromatherapy every 6 hours and at bedtime<br>Drug: Baby aspirin<br>* Baby aspirin 81mg: Twice daily for 6 weeks after surgery<br>Drug: Tylenol/Acetaminophen<br>* Tylenol/Acetaminophen 1000mg: Pre-operative one dose; Every 8 hours for three weeks after surgery<br>Drug: Pregabalin<br>* Pregabalin 25mg: Twice a day for two weeks before surgery; Pre-operative 25-100 mg; Twice a day for two weeks after surgery<br>Drug: Prednisone<br>* Prednisone 5mg: Daily for three weeks after surgery<br>Drug: Meloxicam<br>* Meloxicam 7.5mg: Twice a day, with food, for two weeks before surgery; Twice a day, with food, for two weeks after surgery<br>Drug: Prilosec<br>* Prilosec 20mg: Daily for two weeks before surgery; Daily for for two weeks after surgery<br>Drug: Tramadol<br>* Rescue pain medicine Tramadol 50mg up to three times a day as needed will be provided for rescue pain<br>Drug: Voltaren<br>* Voltaren 1% topical arthritis gel up to 4 times daily pre-operative only<br>Drug: Zofran<br>* Zofran 4 mg pre-operative<br>Drug: Pepcid<br>* Pepcid 20 mg pre-operative<br>Drug: Reglan<br>* Reglan 10 mg pre-operative<br>Drug: Versed<br>* Versed 2 mg pre-operative<br>Drug: Lidocaine<br>* Lidocaine (preservative free) height based dosing for subarachnoid block intraoperatively<br>Drug: Propofol<br>* Propofol 10-125 mcg/kg/min intraoperative<br>Drug: Ancef<br>* Ancef 2-3 gm weight-based dosing intraoperative<br>Drug: Tranexamic Acid (TXA)<br>* Tranexamic Acid (TXA) 2 gm intraoperative<br>Drug: Decadron<br>* Decadron 10 mg intraoperative<br>Drug: Bupivacaine hydrochloride<br>* Local anaesthetic 0.5% bupivacaine hydrochloride intraoperative<br>Drug: Toradol<br>* Toradol nonsteroidal anti-inflammatory drug max 30 mg intraoperative<br>|
| No Intervention: Retrospective control underwent opioid drug regimen<br>Retrospective controls that underwent unilateral total hip replacement surgery and used opioid drug regimen perioperatively | |
| No Intervention: Professional Staff<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip replacement, Opioid free, Perioperative period, Team work