Can Intranasal Ketorolac Tromethamine Prescribed Postoperatively After Major Female Pelvic Reconstructive Surgery Reduce Consumption of Prescribed Narcotics?
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Morphine mEqs
研究概览
简要总结
The ongoing opioid epidemic has altered both how physicians prescribe narcotics and patients' perceptions of those prescriptions. Along with increased scrutiny regarding the quantity of opioids that be may prescribed after acute injury, for chronic conditions and following surgery the healthcare industry as a whole continues to search for alternative medications that provide adequate pain relief and have a reduced tendency for abuse/dependence/addition. To that end this study has the following aims:
-
To evaluate the amount of opioids consumed following minimally invasive, female pelvic surgery when patients' postoperative pain is managed via:
-
Acetaminophen plus Ibuprofen plus breakthrough pain opioids (Standard protocol)
-
Acetaminophen plus Intranasal Ketorolac Tromethamine plus opioids for breakthrough pain (Sprix protocol)
-
Patient satisfaction with the aforementioned methods
-
Evaluate and compare pain scores via validated questionnaire
Hypothesis:
Primary:
- Patients prescribed intranasal Ketorolac (Sprix protocol) will consume significantly less Morphine Milliequivalents (mEqs) of narcotics compared to the standard protocol following minimally invasive female pelvic surgery.
Secondary:
- Patients in the Sprix protocol will have lower Visual Analog Scale (VAS) measures of pain which will be measured on a 0-10 scale where 0 denotes no pain and 10 denotes maximum experience of pain
- Patients in the Sprix protocol will have lower numeric pain score and on POD#4
- Patients in the Sprix protocol will have higher Quality of Recovery 40 (QoR-40 )scores on POD#1
- Patients in the Sprix protocol will have higher QoR-40 scores on POD#4
- Patients will not have any significant difference in overall surgical satisfaction on POD#1 and POD#4 using a numerical satisfaction score
- Patients in the Sprix protocol will be more likely to consume no narcotics at all once discharged to home
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years of age
- •Weight ≥ 110lbs
- •English Speaking and Reading
- •All consecutive, consenting female patients undergoing Pelvic Organ Prolapse (POP) surgery - vaginal prolapse surgery, laparoscopic vaginal prolapse surgery or robotic assisted vaginal prolapse surgery - with or without Bilateral or Unilateral Salpingoopherectomy, with or without concomitant hysterectomy, with or without urinary anti-incontinence surgery
排除标准
- •Patients taking opioids chronically at the time of surgery
- •History of Coronary Artery Bypass Graft (CABG)
- •History of peptic ulcer disease or bleeding in the stomach or intestines
- •History of asthma attack, hives, or other allergic reaction with aspirin or any other Non-Steroidal Anti-inflammatory Drug (NSAID)
- •Uncontrolled hypertension at the time of consent and/or surgery
- •History of renal impairment as defined by blood creatinine of 1.1 or greater at any time
研究组 & 干预措施
Sprix
To compare the total amount of opioid consumption, as measured by morphine mEq, consumed in patients immediately postoperative from minimally invasive female pelvic reconstructive surgery - they will be prescribed regimen of Sprix 30.5mg Intranasal q 6-8 hour up to 4 times daily + Acetaminophen 650 mg PO q 6- 8 hours + rescue narcotics (as above) for breakthrough pain during the day of surgery and the following 4 postoperative days.
干预措施: Sprix (Drug)
结局指标
主要结局
Morphine mEqs
时间窗: As measured from the day of surgery to 4 days post operative
The amount of narcotics consumed postoperatively as measure by Morphine milliequivalents
次要结局
- Patient's perception of current pain(Day of surgery to 4 days postoperatively)
- Patient Satisfaction(Day of surgery to 4 days postoperative)
研究者
Sean Francis, MD
Chairperson & Professor
University of Louisville