NCT04766996

PROUD Study - Preventing Opioid Use Disorders

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Anesthesia
• Opioid Use

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-05-17
• Primary completion: 2021-12-27
• Completion: 2021-12-27
• First posted: 2021-02-23
• Last updated: 2023-06-22
• Results posted: 2023-06-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study