Effect of Ketorolac Administration on Post-operative Narcotic Utilization and Union Rates in Great Toe Arthrodesis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Quantitative pain management - measured using a study survey.
研究概览
简要总结
This study reviews if taking ketorolac, after a joint fusion procedure, can decrease the need for taking oxycodone (standard of care) for pain relief. The study also investigates if ketorolac affects bone healing after surgery.
详细描述
This study reviews if taking ketorolac, after a joint fusion procedure, can decrease the need for taking oxycodone (standard of care) for pain relief. The study also investigates if ketorolac affects bone healing 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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 - 75 years.
- •Women of childbearing potential must have a negative serum or urine pregnancy test results within 24 hours before the first dose of ketorolac.
- •Primary elective great toe MTP arthrodesis (CPT 28750). Other forefoot procedures often performed in conjunction with toe fusion will be included (CPT codes 28308, 28285, 28270).
排除标准
- •Chronic pain syndrome, CRPS or fibromyalgia
- •Revision procedures
- •Use of allograft bone at the fusion site
- •Tobacco use
- •Narcotic abuse or IV drug abuse
- •Any CPT codes involving the midfoot, hindfoot, and/or ankle
- •Unable to take NSAIDs secondary to medical comorbidities such as kidney disease (impaired renal function with CrCl ≤ 50 ml/min) or gastric ulcers
- •Weight < 50 kg
- •Does not speak or read English
- •If pregnant or planning to become pregnant or breastfeeding
- •Non-independent dweller (prisoner)
研究组 & 干预措施
Group 2 (Treatment group) - Oxycodone and Ketorolac
Subjects randomized to this group will receive oxycodone and ketorolac for postop pain management.
干预措施: Ketorolac (Drug)
Group 1 (Control group) - Oxycodone only
Subjects randomized to this group will receive oxycodone for postop pain management (standard of care).
干预措施: Oxycodone (Drug)
Group 2 (Treatment group) - Oxycodone and Ketorolac
Subjects randomized to this group will receive oxycodone and ketorolac for postop pain management.
干预措施: Oxycodone (Drug)
结局指标
主要结局
Quantitative pain management - measured using a study survey.
时间窗: 14 days after the surgery
To study if postop ketorolac provides effective pain relief and helps reduce the need to take oxycodone. Participants will complete a short survey on Days 3, 7, and 14 after surgery. The survey will ask the following set of questions- * number of pills (oxycodone and/or ketorolac) consumed * if the pain medicine(s) needed to be refilled * discontinuation date \& reason * side effects, if any * the effectiveness of the pain medicine(s) * preference for ketorolac or oxycodone, if applicable
Pain scores - collected at baseline (standard of care) and for the study using a study survey on days 3, 7, and 14 after surgery.
时间窗: From baseline to 14 days after the surgery
To study if postop ketorolac provides effective pain relief and helps reduce the need to take oxycodone. Participants will complete a short survey on Days 3, 7, and 14 after surgery. Participants will be asked to provide VAS pain scores, on a scale of 1-10, for the past 24 hours on Days 3, 7, and 14 after surgery.
次要结局
未报告次要终点