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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bunion of Unspecified Foot, Bunionette of Unspecified Foot, Hammertoe, Ankle Fractures, Achilles Tendon Surgery

Intervention / Treatment
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* Drug: Acetominophen
* Drug: Toradol
* Drug: Meloxicam
* Drug: Cyclobenzaprine
* Drug: Lyrica


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multimodal Pain Pathway<br>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<br>* 1,000 mg every 6 hours<br>* Other names: Tylenol;Drug: Toradol<br>* 10 mg every 6 hours, days 0-3<br>* Other names: Ketorolac;Drug: Meloxicam<br>* 15 mg once daily, beginning post-op day 4<br>* Other names: Mobic;Drug: Cyclobenzaprine<br>* 10 mg every 8 hours<br>* Other names: Flexeril;Drug: Lyrica<br>* 75 mg every 12 hours<br>* Other names: Pregabalin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with opioid-free multimodal postoperative protocol. | 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. | 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 | 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 | 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 | 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 |