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

Ankle Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04771741
• Other study ID #: Pro00099067
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: April 26, 2023

Study information

• Verified date: April 2023
• Source: Prisma Health-Midlands
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 26, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Acetominophen
1,000 mg every 6 hours
• Toradol
10 mg every 6 hours, days 0-3
• Meloxicam
15 mg once daily, beginning post-op day 4
• Cyclobenzaprine
10 mg every 8 hours
• Lyrica
75 mg every 12 hours

Locations

Country	Name	City	State
United States	Prisma Health Midlands	Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Prisma Health-Midlands

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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