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

Completed

• Conditions: Hammertoe; Bunion of Unspecified Foot; Ankle Fractures; Achilles Tendon Surgery; Bunionette of Unspecified Foot
• Interventions: Drug: Acetominophen; Drug: Toradol; Drug: Meloxicam; Drug: Cyclobenzaprine; Drug: Lyrica

• Registration Number: NCT04771741
• Lead Sponsor: Prisma Health-Midlands

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.

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-02-18
• Study First Submitted QC: 2021-02-23
• Study First Posted: 2021-02-25
• Primary Completion: 2022-12-31
• Status Verified: 2023-04
• Study Completion: 2023-04-26
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Multimodal Pain Pathway	Acetominophen	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
Multimodal Pain Pathway	Lyrica	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
Multimodal Pain Pathway	Cyclobenzaprine	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
Multimodal Pain Pathway	Toradol	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
Multimodal Pain Pathway	Meloxicam	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

Primary Outcome Measures

Name	Time	Method
Patient satisfaction with opioid-free multimodal postoperative protocol.	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.
Rate of failure of opioid-free multimodal postoperative protocol.	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 Outcome Measures

Name	Time	Method
Post-operative Pain: Day 1	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.
Post-operative Pain: Day 3	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.
Post-operative Pain: Day 8	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.

Trial Locations

Locations (1)

Prisma Health Midlands; 🇺🇸 Columbia, South Carolina, United States