PROUD Study - Preventing Opioid Use Disorders

Summary

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

Conditions

• Anesthesia
• Opioid Use

Interventions

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

Sponsors & Collaborators

• Emory University

  lead OTHER

Principal Investigators

• Wiltse Nicely, PhD, CRNA · Emory University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-17

Primary Completion

2021-12-27

Completion

2021-12-27

FDA Drug

Yes

Countries

• United States

Study Locations