The Effect of Intravenous Acetaminophen on Post-operative Pain and Narcotic Consumption in Vaginal Reconstructive Surgery Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total Amount of Narcotic Consumption in the First 24 Hours Post Surgery
研究概览
简要总结
This randomized controlled trial will evaluate the effects of perioperative intravenous (IV) acetaminophen on postoperative narcotic consumption and pain scores in subjects undergoing vaginal reconstructive surgery. One hundred subjects will be randomly assigned to receive either IV acetaminophen or IV placebo. Those in the IV acetaminophen group will receive 1000mg IV every 6 hours for 24 hours beginning prior to anesthesia induction. The control group will receive placebo saline infusions at the same time intervals. All subjects will receive as needed (prn) IV narcotic for additional pain relief. Visual analog scales (VAS) regarding pain will be evaluated at 18 and 24 hours postoperative and immediately prior to discharge. We will also collect total IV narcotic consumption. We hypothesize that subjects receiving IV acetaminophen will have lower VAS scores and decreased total narcotic consumption in comparison to the control group.
详细描述
see brief summary
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between the ages of 18 and 70 years
- •Patients of the Division of Urogynecology at Good Samaritan and Bethesda North Hospitals in Cincinnati, Ohio
- •Scheduled to undergo major vaginal reconstruction
- •Must undergo total vaginal hysterectomy, anterior repair, posterior repair, enterocele repair, and intraperitoneal vault suspension. The addition of suburethral sling is not a cause for exclusion.
排除标准
- •Allergy to acetaminophen
- •Liver disease (chronic or active)
- •Chronic alcohol use (>1 drink/day)
- •Bleeding diathesis
- •Renal disease
- •Opiate dependent or daily use
- •History of chronic pain
- •Mental or cognitive disorder preventing patient to accurately verbalize pain levels
- •Undergoing abdominal or laparoscopic procedures at the time of surgery
- •Allergy to hydromorphone
- •Surgery is not performed under general anesthesia
研究组 & 干预措施
IV Acetaminophen
Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.
干预措施: IV Acetaminophen (Drug)
Saline
Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.
干预措施: IV Acetaminophen (Drug)
结局指标
主要结局
Total Amount of Narcotic Consumption in the First 24 Hours Post Surgery
时间窗: 24 hours
Hydromorphone will be administered for breakthrough pain. The total amount consumed in the first 24 hours post surgery will be recorded.
Pain While Active - 18 hr
时间窗: 18 hours
Post operative pain will be assessed 18 hours after surgery. Pain will be self reported by patients using a 0-100 mm visual analog scale (VAS) with 0 indicating no pain and 100 indicating the worst pain imaginable. A pain score will be collected for pain while active.
次要结局
- Narcotic Associated Side Effects(24 hours)
- Time to First Rescue Narcotic(24 hours)
- Time to Ambulation(1800 minutes)