PROUD Study - Preventing Opioid Use Disorders

NCT04766996 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: STUDY00002021
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anesthesia; Opioid Use

Keywords

Hip replacement; Opioid free; Perioperative period; Team work

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  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)

Study Arms (3)

Prospective cases undergoing non-opioid drug regimen

EXPERIMENTAL

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

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

Retrospective control underwent opioid drug regimen

NO INTERVENTION

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

Professional Staff

NO INTERVENTION

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.

Interventions

Guided mindfulness exercises BEHAVIORAL

Guided Meditation twice daily

Prospective cases undergoing non-opioid drug regimen

Self-administered aromatherapy OTHER

Self-administered aromatherapy every 6 hours and at bedtime

Prospective cases undergoing non-opioid drug regimen

Baby aspirin DRUG

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

Prospective cases undergoing non-opioid drug regimen

Tylenol/Acetaminophen DRUG

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

Prospective cases undergoing non-opioid drug regimen

Pregabalin DRUG

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

Prospective cases undergoing non-opioid drug regimen

Prednisone DRUG

Prednisone 5mg: Daily for three weeks after surgery

Prospective cases undergoing non-opioid drug regimen

Meloxicam DRUG

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

Prospective cases undergoing non-opioid drug regimen

Prilosec DRUG

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

Prospective cases undergoing non-opioid drug regimen

Tramadol DRUG

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

Prospective cases undergoing non-opioid drug regimen

Voltaren DRUG

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

Prospective cases undergoing non-opioid drug regimen

Zofran DRUG

Zofran 4 mg pre-operative

Prospective cases undergoing non-opioid drug regimen

Pepcid DRUG

Pepcid 20 mg pre-operative

Prospective cases undergoing non-opioid drug regimen

Reglan DRUG

Reglan 10 mg pre-operative

Prospective cases undergoing non-opioid drug regimen

Versed DRUG

Versed 2 mg pre-operative

Prospective cases undergoing non-opioid drug regimen

Lidocaine DRUG

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

Prospective cases undergoing non-opioid drug regimen

Propofol DRUG

Propofol 10-125 mcg/kg/min intraoperative

Prospective cases undergoing non-opioid drug regimen

Ancef DRUG

Ancef 2-3 gm weight-based dosing intraoperative

Prospective cases undergoing non-opioid drug regimen

Tranexamic Acid (TXA) DRUG

Tranexamic Acid (TXA) 2 gm intraoperative

Prospective cases undergoing non-opioid drug regimen

Decadron DRUG

Decadron 10 mg intraoperative

Prospective cases undergoing non-opioid drug regimen

Bupivacaine hydrochloride DRUG

Local anaesthetic 0.5% bupivacaine hydrochloride intraoperative

Prospective cases undergoing non-opioid drug regimen

Toradol DRUG

Toradol nonsteroidal anti-inflammatory drug max 30 mg intraoperative

Prospective cases undergoing non-opioid drug regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prospective study participants undergoing unilateral total hip replacement surgery between the months of February through May, 2021
• 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
• All staff that participate in the implementation of the opioid free surgical protocol.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University Orthopaedic and Spine Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Interventions

Acetaminophen; Pregabalin; Prednisone; Meloxicam; Omeprazole; Tramadol; Diclofenac; Ondansetron; Famotidine; Metoclopramide; Midazolam; Lidocaine; Propofol; Cefazolin; Tranexamic Acid; Calcium Dobesilate; Bupivacaine; Ketorolac Tromethamine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Thiazines; Sulfur Compounds; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids; Phenylacetates; Acids, Carbocyclic; Imidazoles; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring; Benzamides; para-Aminobenzoates; Aminobenzoates; Benzoates; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Benzodiazepines; Benzazepines; Cephalosporins; beta-Lactams; Lactams; Cyclohexanecarboxylic Acids; Benzenesulfonates; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Indomethacin

Limitations and Caveats

This study aimed to enroll a total of 170 participants. Due to staffing issues and the coronavirus disease 2019 (COVID-19) pandemic, this trial was terminated early and therefore the retrospective data was not collected.

Results Point of Contact

• Title: Kelly Wiltse Nicely, MD
• Organization: Emory University

kelly.wiltse.nicely@emory.edu

404-727-6946

Study Officials

• Wiltse Nicely, PhD, CRNA

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Matched Prospective Case with Retrospective Control Study and Staff Survey

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: February 23, 2021
• Study Start: May 17, 2021
• Primary Completion: December 27, 2021
• Study Completion: December 27, 2021
• Last Updated: June 22, 2023
• Results First Posted: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available for sharing beginning 6 months and ending 36 months following article publication.
• 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

Locations

US (1)