Assessment of Medrol Dosepak to Reduce Opioid Consumption in Foot and Ankle Surgical Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Post operative Nausea
研究概览
简要总结
This clinical trial aims to determine the effects of a 6-day low-dose methylprednisolone course on pain, nausea, and total opioid consumption in patients undergoing foot and ankle surgeries.
The secondary objective of the study is to determine and monitor the effects of the course on complications following surgery and patient-reported outcomes
详细描述
The opioid epidemic continues to create a lasting impact on society, leading researchers to focus on ways to decrease opioid prescription rates and subsequently, opioid consumption. Opioid-naïve patients undergoing minor to major surgeries have been shown statistically to be largely affected.1 This includes significant numbers resulting from forefoot surgery specifically with around 6.2% of the mentioned population being at risk for new persistent opioid use.
This has provoked researchers to seek a new route that decreases exposure to opioid use through proposals for multimodal pain regimes.
A recent addition to some of these proposed treatments has been a 6-day low-dose oral methylprednisolone taper beginning on the day of surgery. This has been tested with "terrible triad" elbow injuries, distal radius fractures, and total shoulder arthroplasties with promising results showing decreased consumption of the as-needed opioid prescription. Furthermore, the results of these studies show a significant decrease in pain and increased range of motion following surgery. This is likely due to the anti-inflammatory functioning of glucocorticoids, without inhibiting the healing process.
Based upon the findings stated above, the proposed research will attempt to apply this new pain regime to foot and ankle surgeries, specifically forefoot, ankle, and Achilles surgeries, to take another step towards bettering perioperative care with opioid-free treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Unblinded
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Emory Orthopedic patients undergoing foot and ankle surgery
排除标准
- •Concurrent or significant injuries to other bones or organs
- •Local infections
- •History of alcohol or medical abuse, including prior opioid abuse
- •History of severe heart disease, renal failure, liver dysfunction, active peptic ulcer disease, diabetes, rheumatoid arthritis, neurological or psychiatric diseases that could influence pain perception
- •Pre-existing immune suppression
- •Those deemed possibly non-compliant by the study team and,
- •All vulnerable populations (those unable to give consent, juveniles, pregnant women, prisoners, cognitively impaired and non-English speaking).
研究组 & 干预措施
Medrol
The group will be given Medrol Dosepak in a tapered, low-dose manner, orally once a day.
Subjects will be sent home with a pain journal where they will record their pain and nausea 3 times daily starting the day of surgery and the following 7 days along with their daily hydrocodone consumption. These journals will be collected at their 2-week post-op appointment which is scheduled ± 1 week. In this appointment, subjects will also be evaluated for complications.
干预措施: medrol dosepak (Drug)
Medrol
The group will be given Medrol Dosepak in a tapered, low-dose manner, orally once a day.
Subjects will be sent home with a pain journal where they will record their pain and nausea 3 times daily starting the day of surgery and the following 7 days along with their daily hydrocodone consumption. These journals will be collected at their 2-week post-op appointment which is scheduled ± 1 week. In this appointment, subjects will also be evaluated for complications.
干预措施: HYDROcodone Oral Tablet (Drug)
Standard of Care
Each subject will receive the standard pain regime of both surgeons. This includes a nerve block before surgery for pain prevention. While in surgery, the subject will receive 10 mg of dexamethasone intravenously. Post-surgery, each subject will be instructed to take vitamin C for nerve pain and vitamin D for bone healing. They will also be provided with a prescription of aspirin for deep vein thrombosis (DVT) prophylaxis, ondansetron (Zofran) for nausea, and Colace for constipation relief. Both groups will receive a prescription of 20 5 mg hydrocodone pills to be taken as needed for pain, 1 every 6 hours
Subjects will be sent home with a pain journal where they will record their pain and nausea 3 times starting the day of surgery and the following 7 days along with their daily hydrocodone consumption. Journals will be collected at their 2-week post-op appointment which is scheduled ± 1 week. Subjects will also be evaluated for complications
干预措施: HYDROcodone Oral Tablet (Drug)
结局指标
主要结局
Post operative Nausea
时间窗: Baseline (Day 0), 7 days post op
The subjects will report nausea along the visual analog scale (VAS scale), which they will be educated on before surgery. A VAS for nausea is a straight line with one end labeled "no nausea" and the other end labeled "worst nausea imaginable". The patient marks a point on the line to indicate their nausea level. The distance from the "no nausea" end of the line is used to score the nausea intensity
Post operative pain
时间窗: Baseline, 0.25 months, 1.5 months, 3 months, 6 months
The subject will measure pain along the visual analog scale (VAS scale), which they will be educated on before surgery. A VAS for pain is a straight line with one end labeled "no pain" and the other end labeled "worst pain imaginable". The patient marks a point on the line to indicate their pain level. The distance from the "no pain" end of the line is used to score the pain intensity
Post operative opioid consumption
时间窗: Baseline (Day 0), 7 days post op
Total number of opioids consumed each day will be captured.
次要结局
- Complications due to the Medrol Dosepak(1.5 months, 3 months, 6 months)
- Patient reported outcomes(Baseline (pre operative assessment), Post operation (6 months))
研究者
Jason Bariteau
Associate Professor
Emory University