Application of the ICE-T Postoperative Multimodal Pain Regimen to Laparoscopic Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Opioid analgesic usage in the 24 hours immediate post-operative period
研究概览
简要总结
This is a randomized controlled trial evaluating whether application of ice packs and scheduled ketorolac to the surgical site after laparoscopic hysterectomy reduces need for narcotic medications.
详细描述
Patients who undergo laparoscopic hysterectomy and chose to participate in the study will be randomized to either receive the standard post-surgical analgesic protocol (control group) or the standard post-surgical analgesic protocol plus scheduled ketorolac and surgical site ice packs. Usage of narcotic analgesics for breakthrough pain will be monitored and compared between cohorts. All care received by test subjects will be standard of care, with the only difference being the use of ice packs and scheduled ketorolac.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females, 18-65 years old at time of new patient evaluation, Planned laparoscopic hysterectomy only or hysterectomy with or without unilateral or bilateral oophorectomy or salpingo-oophorectomy by Dr. Corey Wagner, Uterus with expected size greater than 250 grams as determined by bimanual exam or standard of care ultrasound obtained prior to or as part of new patient evaluation
排除标准
- •Diagnosed or suspected endometriosis, Diagnosis of malignant carcinoma of the uterus, ovaries, or fallopian tubes, Diagnosis of severe renal disease (as determined by a GFR of less than 45), Known nonsteroidal anti-inflammatory drug (NSAID) intolerance, History of myocardial infarction, stroke or other cardiovascular disease, Known hypersensitivity or allergic reactions to Acetaminophen, Toradol, Ibuprofen, other NSAIDs, Aspirin or Roxicodone, Previous diagnosis of liver disease or hepatitis, Unable to take Tylenol (acetaminophen), Pre-existing narcotic drug regimens or opioid use disorders, Known diagnosis of or history of peptic ulcer disease, gastrointestinal bleeding or perforation, Known or suspected gastrointestinal obstruction including paralytic ileus, Diagnosis of severe bronchial asthma, Known diagnosis or history of cerebrovascular bleeding, Known bleeding disorder or coagulopathy based on patient history unless excluded by appropriate hematological examination, Daily prescription NSAID use, Adults unable to consent, Pregnancy as determined by urine or serum pregnancy test obtained in women of child-bearing age, Prisoners, Individuals who do not read and understand English
结局指标
主要结局
Opioid analgesic usage in the 24 hours immediate post-operative period
时间窗: 24 hours
Opioid analgesic usage in the 24 hours immediately post-operative as measured in Morphine Milligram Equivalents
次要结局
- Opioid analgesic usage for 6 weeks post-operative(6 weeks)
- Pain scores in the 24 hours immediate post-operative period(24 hours)