Opiate Free Multimodal Pain Pathway in Elective Foot and Ankle Surgery: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Patient satisfaction with opioid-free multimodal postoperative protocol.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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
排除标准
- •<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
研究组 & 干预措施
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
干预措施: Acetominophen (Drug)
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
干预措施: Toradol (Drug)
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
干预措施: Meloxicam (Drug)
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
干预措施: Cyclobenzaprine (Drug)
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
干预措施: Lyrica (Drug)
结局指标
主要结局
Patient satisfaction with opioid-free multimodal postoperative protocol.
时间窗: 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.
时间窗: 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.
次要结局
- Post-operative Pain: Day 1(1 day)
- Post-operative Pain: Day 3(3 days)
- Post-operative Pain: Day 8(8 days)