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临床试验/NCT01291147
NCT01291147已完成4 期

Local Anaesthetic Infusion For Laparoscopic Hysterectomy: A Randomised Controlled Trial

Ashford and St. Peter's Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年2月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

干预措施: Levobupivicaine (Drug)

0.9% Saline

Placebo Comparator

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)

研究者

发起方
Ashford and St. Peter's Hospitals NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

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