Pain Relief After Trapeziectomy Without Opioids: Ibuprofen & Acetaminophen Versus Oxycodone
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 121
- 试验地点
- 4
- 主要终点
- Change of medication consumption and overall amount
研究概览
简要总结
In the US, pain management after surgery for surgical treatment of osteoarthritis at the base of the thumb typically consists of prescription opioids during the early recovery phase. Given the highly addictive nature of prescription opioids, guidelines are being evaluated by hand surgeons to reduce opioid use while still maintaining pain control after surgery. A promising approach is to use non-narcotic medication as the first line of treatment. The purpose of this study is to demonstrate the efficacy of a combination of non-steroidal anti-inflammatory drugs (NSAIDs), ibuprofen and acetaminophen, in comparison to a morphine analogue substance (oxycodone) for pain management in the first 30 days after surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing trapeziectomy for thumb osteoarthritis
- •English proficient,
排除标准
- •Pregnancy
- •Current use of opioids
- •Concurrent surgeries (ex. trapeziectomy combined with carpal tunnel release)
- •Inability to complete study forms (education, cognitive ability, mental status, medical status)
- •Allergy or intolerance to Ibuprofen, Acetaminophen and/or Oxycodone
- •Liver or kidney dysfunction, abnormal liver enzymes restricting use of acetaminophen or ibuprofen
- •History of chronic heart failure, upper gastrointestinal bleeding or coagulopathy
- •History of complex regional pain syndrome
研究组 & 干预措施
NSAIDS
Following surgery will receive NSAID capsules following surgery. Will take online and phone surveys.
干预措施: NSAID capsules (Drug)
Opioids
Following surgery will receive opioid capsules following surgery. Will take online and phone surveys.
干预措施: Opioid capsule (Drug)
结局指标
主要结局
Change of medication consumption and overall amount
时间窗: Every day from the first day after surgery to 30 days post-op.
The number of capsules consumed in the last 24 hours. Consumption rate and overall consumption will be compared between groups to assess efficacy and inform further statistical analyses.
Change of worst daily pain score measured over time
时间窗: Every day from the first day after surgery to 30 days post-op.
Numerical score describing surgical pain at its worst in the last 24 hours, between 1 and 10, 1 being no pain, 10 being the worst possible pain.
Change of least daily pain score measured over time
时间窗: Every day from the first day after surgery to 30 days post-op.
Numerical score describing surgical pain at its least in the last 24 hours, between 1 and 10, 1 being no pain, 10 being the worst possible pain.
Change of average daily pain score measured over time
时间窗: Every day from the first day after surgery to 30 days post-op.
Numerical score describing average surgical pain in the last 24 hours, between 1 and 10, 1 being no pain, 10 being the worst possible pain.
次要结局
- Change in Quick DASH scores over time(Baseline, Post-operative weeks 1, 3, 5, and 8)
- Change in PROMIS-PI scores over time(Baseline, Post-operative weeks 1, 3, 5, and 8)
研究者
Amy Ladd
Professor of Orthopaedic Surgery
Stanford University