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

NCT04771741 | Completed FDA Drug

• 1 other identifier: Pro00099067
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Bunion of Unspecified Foot; Bunionette of Unspecified Foot; Hammertoe; Ankle Fractures; Achilles Tendon Surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Post-operative Pain: Day 1

  1 day

• Post-operative Pain: Day 3

  3 days

• Post-operative Pain: Day 8

  8 days

Study Arms (1)

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; Drug: Toradol; Drug: Meloxicam; Drug: Cyclobenzaprine; Drug: Lyrica

Interventions

Acetominophen DRUG

1,000 mg every 6 hours

Also known as: Tylenol

Multimodal Pain Pathway

Toradol DRUG

10 mg every 6 hours, days 0-3

Also known as: Ketorolac

Multimodal Pain Pathway

Meloxicam DRUG

15 mg once daily, beginning post-op day 4

Also known as: Mobic

Multimodal Pain Pathway

Cyclobenzaprine DRUG

10 mg every 8 hours

Also known as: Flexeril

Multimodal Pain Pathway

Lyrica DRUG

75 mg every 12 hours

Also known as: Pregabalin

Multimodal Pain Pathway

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Prisma Health-Midlands: lead

Study Sites (1)

Prisma Health Midlands

Columbia, South Carolina, 29203, United States

Location

Related Publications (10)

• Haddad DK, Sherman OH. Developing opioid prescribing recommendations in the postoperative orthopedic setting. J Opioid Manag. 2019 Jul/Aug;15(4):333-341. doi: 10.5055/jom.2019.0518.

  PMID: 31637685 BACKGROUND

• Janakiram C, Fontelo P, Huser V, Chalmers NI, Lopez Mitnik G, Brow AR, Iafolla TJ, Dye BA. Opioid Prescriptions for Acute and Chronic Pain Management Among Medicaid Beneficiaries. Am J Prev Med. 2019 Sep;57(3):365-373. doi: 10.1016/j.amepre.2019.04.022. Epub 2019 Aug 1.

  PMID: 31377093 BACKGROUND

• Young JD, Bhashyam AR, Qudsi RA, Parisien RL, Shrestha S, van der Vliet QMJ, Fils J, Losina E, Dyer GSM. Cross-Cultural Comparison of Postoperative Discharge Opioid Prescribing After Orthopaedic Trauma Surgery. J Bone Joint Surg Am. 2019 Jul 17;101(14):1286-1293. doi: 10.2106/JBJS.18.01022.

  PMID: 31318808 BACKGROUND

• Bean BA, Connor PM, Schiffern SC, Hamid N. Outpatient Shoulder Arthroplasty at an Ambulatory Surgery Center Using a Multimodal Pain Management Approach. J Am Acad Orthop Surg Glob Res Rev. 2018 Oct 23;2(10):e064. doi: 10.5435/JAAOSGlobal-D-18-00064. eCollection 2018 Oct.

  PMID: 30656252 BACKGROUND

• Seki H, Ideno S, Ishihara T, Watanabe K, Matsumoto M, Morisaki H. Postoperative pain management in patients undergoing posterior spinal fusion for adolescent idiopathic scoliosis: a narrative review. Scoliosis Spinal Disord. 2018 Sep 12;13:17. doi: 10.1186/s13013-018-0165-z. eCollection 2018.

  PMID: 30214945 BACKGROUND

• Garcia RM, Cassinelli EH, Messerschmitt PJ, Furey CG, Bohlman HH. A multimodal approach for postoperative pain management after lumbar decompression surgery: a prospective, randomized study. J Spinal Disord Tech. 2013 Aug;26(6):291-7. doi: 10.1097/BSD.0b013e318246b0a6.

  PMID: 23887076 BACKGROUND

• Seiter M, Aiyer A. Current Trends in Anesthesia Management in Hallux Valgus. Foot Ankle Clin. 2020 Mar;25(1):47-57. doi: 10.1016/j.fcl.2019.10.002. Epub 2019 Nov 20.

  PMID: 31997746 BACKGROUND

• Lee JK, Kang C, Hwang DS, Lee GS, Hwang JM, Park EJ, Ga IH. An Innovative Pain Control Method Using Peripheral Nerve Block and Patient-Controlled Analgesia With Ketorolac After Bone Surgery in the Ankle Area: A Prospective Study. J Foot Ankle Surg. 2020 Jul-Aug;59(4):698-703. doi: 10.1053/j.jfas.2019.12.001. Epub 2020 Feb 10.

  PMID: 32057624 BACKGROUND

• Michelson JD, Addante RA, Charlson MD. Multimodal analgesia therapy reduces length of hospitalization in patients undergoing fusions of the ankle and hindfoot. Foot Ankle Int. 2013 Nov;34(11):1526-34. doi: 10.1177/1071100713496224. Epub 2013 Jul 8.

  PMID: 23836812 BACKGROUND

• McDonald EL, Daniel JN, Rogero RG, Shakked RJ, Nicholson K, Pedowitz DI, Raikin SM, Bilolikar V, Winters BS. How Does Perioperative Ketorolac Affect Opioid Consumption and Pain Management After Ankle Fracture Surgery? Clin Orthop Relat Res. 2020 Jan;478(1):144-151. doi: 10.1097/CORR.0000000000000978.

  PMID: 31567579 BACKGROUND

MeSH Terms

Conditions

Hammer Toe Syndrome; Ankle Fractures

Interventions

Acetaminophen; Ketorolac Tromethamine; Ketorolac; Meloxicam; cyclobenzaprine; Pregabalin

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases; Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thiazines; Sulfur Compounds; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• J. Benjamin Jackson, MD, MBA

  Prisma Health-Midlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 25, 2021
• Study Start: December 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: April 26, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)