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

April 26, 2023 updated by: Prisma Health-Midlands
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Prisma Health Midlands

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Included in this study will be adult outpatient, elective, primary foot and ankle surgery that is not due to infection performed at Prisma Health Orthopedics.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Drug: Acetominophen
1,000 mg every 6 hours
Other Names:
  • Tylenol
Drug: Toradol
10 mg every 6 hours, days 0-3
Other Names:
  • Ketorolac
Drug: Meloxicam
15 mg once daily, beginning post-op day 4
Other Names:
  • Mobic
Drug: Cyclobenzaprine
10 mg every 8 hours
Other Names:
  • Flexeril
Drug: Lyrica
75 mg every 12 hours
Other Names:
  • Pregabalin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 weeks
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.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day
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 days
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.
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prisma Health-Midlands

Investigators

  • Principal Investigator: J. Benjamin Jackson, MD, MBA, Prisma Health-Midlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

April 26, 2023

Study Registration Dates

First Submitted

February 18, 2021

First Submitted That Met QC Criteria

February 23, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00099067

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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