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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal Pain Pathway | This group will receive the multimodal pain pathway cocktail of medications. This cocktail includes:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetominophen | Drug | 1,000 mg every 6 hours |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| J. Benjamin Jackson, MD, MBA | Prisma Health-Midlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prisma Health Midlands | Columbia | South Carolina | 29203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31637685 | Background | 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. | |
| 31377093 | 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. |
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| Toradol | Drug | 10 mg every 6 hours, days 0-3 |
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| Meloxicam | Drug | 15 mg once daily, beginning post-op day 4 |
|
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| Cyclobenzaprine | Drug | 10 mg every 8 hours |
|
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| Lyrica | Drug | 75 mg every 12 hours |
|
|
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 |
| 31318808 | 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. |
| 30656252 | 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. |
| 30214945 | 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. |
| 23887076 | 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. |
| 31997746 | 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. |
| 32057624 | 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. |
| 23836812 | 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. |
| 31567579 | 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. |
| ID | Term |
|---|---|
| D037801 | Hammer Toe Syndrome |
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D020911 | Ketorolac Tromethamine |
| D020910 | Ketorolac |
| D000077239 | Meloxicam |
| C004704 | cyclobenzaprine |
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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