Local Anaesthetic Infusion For Laparoscopic Hysterectomy: A Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- • Need for 'rescue' analgesia
研究概览
简要总结
More hysterectomies are performed laparoscopically either as a total laparoscopic hysterectomy or as a laparoscopically assisted vaginal hysterectomy. The advantages of laparoscopic surgery include quicker hospital discharge, a shorter convalescence and cost effectiveness when compared to open procedures. Laparoscopic hysterectomies (both total and vaginally assisted) can lead to discomfort which may lead to a delay in discharge from hospital. Continuous infusions of local anaesthetic agents given post operatively to the site of operation have the been subject of trials for several operative procedures. To date however there have not been any properly controlled studies evaluating whether there are benefits of giving a local anaesthetic infusion for 48 hours into the pelvis following a total or vaginally assisted laparoscopic hysterectomy. The investigators therefore propose to investigate whether giving a local anaesthetic infusion in this fashion decreases the amount of rescue and patient controlled analgesia needed, and length of hospital stay. In order to do this the investigators wish to conduct a randomised placebo controlled double blind trial.
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, Investigator, Outcomes Assessor)
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
- •All women undergoing a total laparoscopic or laparoscopically assisted vaginal hysterectomy
排除标准
- •Women undergoing surgery for cancer, or are known to be allergic to local anaesthetic agents.
研究组 & 干预措施
Levobupivicaine
干预措施: Levobupivicaine (Drug)
0.9% Saline
干预措施: 0.9% Saline (Drug)
结局指标
主要结局
• Need for 'rescue' analgesia
时间窗: 48 hours
次要结局
- Amount of patient controlled analgesia needed(48 hours)
- Side effects from rescue analgesia(48 hours)
- • Pain intensity(48 hours)
- Hospital length of stay(48 hours)
- Patient satisfaction with pain relief(48 hours)
