Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy: A Prospective, Randomized, Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
The goal of this clinical trial is to learn whether the medication ketorolac can help manage pain after hip arthroscopy as well or better than the standard opioid-based pain medications. This study focuses on adult patients (over 18 years old) undergoing hip arthroscopy at Henry Ford Health System in Detroit, Michigan. Both men and women are included, and all participants must be able to consent and communicate in English.
The main questions it aims to answer are:
Can ketorolac help control pain as effectively or better than opioids after hip arthroscopy?
Will ketorolac use reduce the amount of opioid medication needed after surgery?
Researchers will compare the group receiving ketorolac to the group receiving standard opioid pain medications to see if ketorolac reduces pain and opioid use after surgery.
Participants will:
Be randomly assigned to one of two groups:
The control group, which receives the current standard pain management protocol (hydrocodone-acetaminophen and diazepam)
The experimental group, which receives the same protocol plus ketorolac and a stomach-protecting medication (omeprazole)
Receive their assigned pain medications after hip arthroscopy
Be asked to:
Take the prescribed medications after discharge
Complete a pain journal for 5 days following surgery, documenting pain levels and any side effects
Complete follow-up surveys and assessments at 2 weeks, 6 weeks, and 3 months after surgery
The main measurement researchers will use is the Visual Analog Scale (VAS) for pain on post-operative day 4. Additional measures include how many narcotic pills are used and results from PROMIS physical function and pain interference scores.
The hope is that ketorolac will provide equal or better pain control without the risks of addiction and side effects associated with opioid medications. If successful, this approach could offer a safer alternative for managing pain after hip arthroscopy. Participants may personally benefit by having effective pain relief with fewer risks, and future patients could benefit from improved pain management options.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing hip arthroscopy over the age of 18 with Dr. T. Sean Lynch
- •Diagnosis of femoroacetabular impingement (FAI)
排除标准
- •Patients with inability to consent and/or do not speak English
- •Patients with conditions contraindicated with NSAIDs (medication allergy, peptic ulcer disease, bleeding diathesis, and renal disease)
- •Patients with history of drug and alcohol use disorder
- •Patients with chronic analgesia (filled two opioid prescriptions within 6 months of the surgery)
- •Patients with psychotropic medication usage
- •Patients who take pentoxifylline, probonecid, aspirin, and/or NSAIDs who cannot stop taking it for the study
- •Patients who are not discharged same day after surgery
研究组 & 干预措施
Control
The standard of care/control pain protocol
干预措施: Control (Standard treatment) (Drug)
Ketorolac
Intra-operative IV and Oral doses of Ketorolac plus Standard of care
干预措施: Ketorolac (Drug)
Ketorolac
Intra-operative IV and Oral doses of Ketorolac plus Standard of care
干预措施: Omeprazole (Drug)
Ketorolac
Intra-operative IV and Oral doses of Ketorolac plus Standard of care
干预措施: Control (Standard treatment) (Drug)
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: 5 days
A validated tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with the far-left end meaning no pain and the far-right end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. It may be used to help choose the right dose of pain medicine.
次要结局
- PROMOIS- PF(2 weeks, 6 weeks, 3 months)
- PROMOIS- PI(2 weeks, 6 weeks, 3 months)
研究者
Thomas Lynch
Sports Medicine Orthopedic Surgeon
Henry Ford Health System