Preemptive Oral vs Intravenous Acetominophen for Postoperative Pain in Minimally Invasive Gynecologic Surgery: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Pain - VAS
研究概览
简要总结
Hypothesis: Postoperative pain will be equivalent in patients receiving preemptive oral acetaminophen as compared to patients receiving preemptive intravenous acetaminophen following minimally invasive benign gynecologic surgery.
Primary outcome:
• Difference in postoperative pain comparing preemptive use of PO versus IV acetaminophen
o Mean Visual analog Scale (VAS) scores will be compared between the intervention group (PO acetaminophen) and the control group (IV acetaminophen).
Secondary outcomes:
- Difference in postoperative analgesic use between groups
o Narcotics, NSAIDs
- Difference in postoperative N/V between groups
o Patient rated measure - none, mild, moderate, severe
- Cost comparison between drugs
详细描述
Hypothesis: Postoperative pain will be equivalent in patients receiving preemptive oral acetaminophen as compared to patients receiving preemptive intravenous acetaminophen following minimally invasive benign gynecologic surgery.
Importance/significance: Adequate control of postoperative pain is important for patient satisfaction, adequate healing, and optimizing length of stay. The idea of preemptive analgesia (giving an analgesic prior to first skin incision to prevent sensitization of nerve pathways from the trauma of surgery) has been shown in many studies to improve postoperative pain. Intravenous acetaminophen has been found to be an effective agent when given preemptively, and many surgeons have adopted this practice. Unfortunately, the IV formulation of acetaminophen, unlike the oral formulation, is expensive as it is a relatively new drug. There are other oral analgesics (i.e. Celebrex) that have been found to be efficacious for postoperative pain control when given preemptively. There are no studies in gynecologic surgery, however, comparing the effectiveness of PO acetaminophen with IV acetaminophen. Given that PO acetaminophen is significantly cheaper than the IV formulation, this could result in cost savings for hospital systems while maintaining adequate patient comfort and satisfaction.
Primary outcome:
- Difference in postoperative pain comparing preemptive use of PO versus IV acetaminophen
- Mean VAS scores will be compared between the intervention group (PO acetaminophen) and the control group (IV acetaminophen).
Secondary outcomes:
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age or older scheduled to undergo robotic-assisted laparoscopic hysterectomy for benign conditions.
排除标准
- •Known or suspected malignancy,
- •Active liver/renal disease,
- •Chronic alcohol use/alcoholism,
- •Allergy to acetaminophen,
- •Conversion to laparotomy,
- •hx gastroparesis,
- •Poorly controlled insulin dependent diabetes or gastric bypass surgery,
- •Regular/recent (past 6 months) narcotic use,
- •Inability to swallow pills.
研究组 & 干预措施
Oral Acetominophen Arm
1000 mg acetominophen oral
干预措施: acetominophen (Drug)
Oral Acetominophen Arm
1000 mg acetominophen oral
干预措施: Acetaminophen (Drug)
Intravenous
1000 mg acetominophen intravenous
干预措施: acetominophen (Drug)
Intravenous
1000 mg acetominophen intravenous
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Pain - VAS
时间窗: 2 hours
Pain level 2 hours post treatment
次要结局
- Pain - VAS(24 hours)