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

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ClinicalTrials.gov Identifier: NCT04771741
Recruitment Status : Enrolling by invitation
First Posted : February 25, 2021
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Bunion of Unspecified Foot Bunionette of Unspecified Foot Hammertoe Ankle Fractures Achilles Tendon Surgery Drug: Acetominophen Drug: Toradol Drug: Meloxicam Drug: Cyclobenzaprine Drug: Lyrica

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Opiate Free Multimodal Pain Pathway in Elective Foot and Ankle Surgery: A Prospective Study
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

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 Name: Tylenol

Drug: Toradol
10 mg every 6 hours, days 0-3
Other Name: Ketorolac

Drug: Meloxicam
15 mg once daily, beginning post-op day 4
Other Name: Mobic

Drug: Cyclobenzaprine
10 mg every 8 hours
Other Name: Flexeril

Drug: Lyrica
75 mg every 12 hours
Other Name: Pregabalin




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04771741


Locations
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United States, South Carolina
Prisma Health Midlands
Columbia, South Carolina, United States, 29203
Sponsors and Collaborators
Prisma Health-Midlands
Investigators
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Principal Investigator: J. Benjamin Jackson, MD, MBA Prisma Health-Midlands
Publications:

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Responsible Party: Prisma Health-Midlands
ClinicalTrials.gov Identifier: NCT04771741    
Other Study ID Numbers: Pro00099067
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Hammer Toe Syndrome
Ankle Fractures
Fractures, Bone
Wounds and Injuries
Foot Deformities
Musculoskeletal Diseases
Acetaminophen
Ketorolac
Ketorolac Tromethamine
Meloxicam
Pregabalin
Cyclobenzaprine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors