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

NCT ID: NCT04771741

Last Updated: 2023-04-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2023-04-26

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Multimodal Pain Pathway

This group will receive the multimodal pain pathway cocktail of medications. This cocktail includes:

• Tylenol (acetominophen), 1000 mg, every 6 hours as needed for pain
• Ketorolac (Toradol), 10 mg, every 6 hours as needed for pain until post-op day 3
• Mobic (Meloxicam), 15 mg once daily, beginning on post-op day 4
• Flexeril (Cyclobenzaprine), 10 mg every 8 hours as needed for pain
• Pregabalin (Lyrica), 75 mg every 12 hours as needed for pain

Acetominophen

Intervention Type: DRUG

1,000 mg every 6 hours

Toradol

Intervention Type: DRUG

10 mg every 6 hours, days 0-3

Meloxicam

Intervention Type: DRUG

15 mg once daily, beginning post-op day 4

Cyclobenzaprine

Intervention Type: DRUG

10 mg every 8 hours

Lyrica

Intervention Type: DRUG

75 mg every 12 hours

Interventions

Acetominophen

1,000 mg every 6 hours

Intervention Type: DRUG

Toradol

10 mg every 6 hours, days 0-3

Intervention Type: DRUG

Meloxicam

15 mg once daily, beginning post-op day 4

Intervention Type: DRUG

Cyclobenzaprine

10 mg every 8 hours

Intervention Type: DRUG

Lyrica

75 mg every 12 hours

Intervention Type: DRUG

Other Intervention Names

Tylenol; Ketorolac; Mobic; Flexeril; Pregabalin

Eligibility Criteria

Inclusion Criteria

• ≥18 years of age
• Outpatient, elective, primary foot and ankle surgery not due to infection including:
• Bunion or bunionette surgery, hammertoe surgery, ankle fracture, Achilles tendon surgery (primary mid-substance repair, Haglund's deformity correction with debridement), ankle arthroscopy

Exclusion Criteria

• <18 years of age
• Undergoing revision surgery
• Allergic to more than 1 medication listed in protocol
• Creatinine clearance >1.5
• Known end-stage renal, stage 2 or higher
• History of GI bleed, ulcer, NSAID-induced gastritis, and/or gastric bypass
• History of active liver disease or Child-Pugh Class 2 liver failure or above
• History of pain syndromes including: fibromyalgia, complex regional pain syndrome/reflex sympathetic dystrophy, hyperalgesia
• Inability to undergo regional anesthesia due to inability to obtain nerve block, prior nerve damage or anatomy, or anesthesiologic best judgement
• Currently pregnant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prisma Health-Midlands

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

J. Benjamin Jackson, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Prisma Health-Midlands

Locations

Prisma Health Midlands

Columbia, South Carolina, United States

Countries

United States

References

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Other Identifiers

Pro00099067

Identifier Type: -

Identifier Source: org_study_id