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Completed

NCT Number: NCT04771741

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

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.

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Key information

Conditions

Bunion of Unspecified Foot Achilles Tendon Surgery Ankle Fractures Ankle Injuries Bunionette of Unspecified Foot Foot Deformities Fractures, Bone Hammer Toe Syndrome Hammertoe Leg Injuries Musculoskeletal Diseases Wounds and Injuries

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Prisma Health Midlands

Columbia, South Carolina, 29203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetominophen

Drug

1,000 mg every 6 hours

Other names: Tylenol

Toradol

Drug

10 mg every 6 hours, days 0-3

Other names: Ketorolac

Meloxicam

Drug

15 mg once daily, beginning post-op day 4

Other names: Mobic

Cyclobenzaprine

Drug

10 mg every 8 hours

Other names: Flexeril

lyrica

Drug

75 mg every 12 hours

Other names: Pregabalin

Primary outcomes

  1. Patient satisfaction with opioid-free multimodal postoperative protocol.

    Time frame: 2 weeks

    Study participants will complete a survey at the 2 week follow-up visit asking yes or no if they were satisfied with the opioid-free pain management protocol.

  2. Rate of failure of opioid-free multimodal postoperative protocol.

    Time frame: 2 weeks

    At 2 weeks, patients will be asked yes or no if they used any additional medications for pain outside of prescriptions that were provided in the opioid-free multimodal pain protocol.

Secondary outcomes

  1. Post-operative Pain: Day 1

    Time frame: 1 day

    Study participants will be asked to rate their pain using a Visual Analog Scale (VAS) from 0 (no pain) to 10 (worst pain) at post-operative day 1.

  2. Post-operative Pain: Day 3

    Time frame: 3 days

    Study participants will be asked to rate their pain using a Visual Analog Scale (VAS) from 0 (no pain) to 10 (worst pain) at post-operative day 3.

  3. Post-operative Pain: Day 8

    Time frame: 8 days

    Study participants will be asked to rate their pain using a Visual Analog Scale (VAS) from 0 (no pain) to 10 (worst pain) at post-operative day 8.

Sponsors and collaborators

Lead sponsor

Prisma Health-Midlands

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Feb 25, 2021
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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