Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery: A Randomized Trial Comparing Patient-Controlled Intravenous Analgesia (PCA) to Scheduled Intravenous Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Patient Pain Control
研究概览
简要总结
The investigators hypothesize that patient controlled analgesia (PCA) provides superior pain relief and patient satisfaction when compared to scheduled intravenous analgesia following vaginal reconstructive surgery.
详细描述
The investigators hypothesize that patient controlled analgesia (PCA) provides superior pain relief and patient satisfaction when compared to scheduled intravenous analgesia following vaginal reconstructive surgery.
In order to determine if there is a significant correlation, secondary outcomes will include the daily and total narcotic volume used, common side effects from the opioid including nausea, vomiting, or pruritis, length of hospital stay, timing of flatus and first bowel movement, all complications, and procedure performed.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patients will be limited to those from the Division of Urogynecology to ensure similar surgical techniques. They will be between the ages of 18 and 70 and undergoing major vaginal reconstruction.
- •All patients must undergo vaginal reconstructive surgery including: anterior repair, posterior repair, and intraperitoneal vaginal vault suspension. The addition of vaginal hysterectomy, enterocele repair, or suburethral sling is not cause for exclusion.
排除标准
- •Any patient who has an allergy to hydromorphone/Dilaudid.
- •Any patient already taking chronic opioids, defined as daily use.
- •All patients with renal insufficiency or failure.
- •All patients with liver failure.
- •Any patient who is not having general anesthesia.
- •Any patient undergoing abdominal or laparoscopic procedures: sacral colpopexy, laparoscopic hysterectomy or oophorectomy, Burch procedure, or any procedure that enters the abdominal fascia.
研究组 & 干预措施
Scheduled IV post op
Patient's will receive scheduled nurse administered IV pain medications post operatively.
干预措施: Dilaudid IV Scheduled (Drug)
PCA post op
Patients will receive PCA for pain control post operatively.
干预措施: Dilaudid PCA (Drug)
结局指标
主要结局
Patient Pain Control
时间窗: post operative day 1
Patient's reported pain on a VAS on all postoperative day one.
次要结局
- Patient Satisfaction with Pain Control(post operative day 1)
- patient perceived pain at 2 weeks(2 weeks post op)
- patient dissatisfaction with pain control at 2 weeks(2 weeks post op)