NCT04771741

Opiate Free Multimodal Pain Pathway in Elective Foot and Ankle Surgery: A Prospective Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 72 (actual)
• Sponsor: Prisma Health-Midlands · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Orthopedic surgeons frequently prescribe and over-prescribe narcotic pain medications during the postoperative period, despite the ongoing opioid crisis in the United States. While opioid-free multimodal pathways have shown promising results, there remains a lack of published literature evaluating opiate-free multimodal pain protocols for elective outpatient foot and ankle surgeries. This study aims to evaluate post-operative pain following the use of an opioid-free pain treatment plan for patients undergoing foot and ankle surgeries.

Detailed description

Despite the presence and increased understanding of the opioid crisis in the United States, orthopedic surgeons frequently prescribe and over-prescribe narcotic pain medications during the postoperative period. In an effort to minimize narcotic analgesia and its potential side effects, opioid-free multimodal pathways have been developed in many orthopaedic sub-specialties with promising results. There have been early studies reporting the results of non-narcotic protocols during the intra-operative period. Likewise, there have been several studies reporting the results of inpatient non-narcotic pain protocols in select foot and ankle surgeries. However, there remains a lack of published literature evaluating opiate-free multimodal pain protocols for elective outpatient foot and ankle surgeries. Currently, our practice utilizes an opioid-free post-operative pain protocol for patients undergoing elective outpatient foot and ankle surgery. The goal of this study is to evaluate post-operative pain using this opioid-free multimodal pain protocol at days 1,3, and 8 following elective outpatient foot and ankle surgery.

Conditions

• Bunion of Unspecified Foot
• Bunionette of Unspecified Foot
• Hammertoe
• Ankle Fractures
• Achilles Tendon Surgery

Interventions

Type	Name	Description
DRUG	Acetominophen	1,000 mg every 6 hours
DRUG	Toradol	10 mg every 6 hours, days 0-3
DRUG	Meloxicam	15 mg once daily, beginning post-op day 4
DRUG	Cyclobenzaprine	10 mg every 8 hours
DRUG	Lyrica	75 mg every 12 hours

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-12-31
• Completion: 2023-04-26
• First posted: 2021-02-25
• Last updated: 2023-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study