A Randomised Controlled Trial of Intravaginal Lignocaine Injection Versus Placebo for Analgesia During Oocyte Recovery in an IVF Cycle
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Total dose of iv fentanyl used during oocyte collection
研究概览
简要总结
The purpose of this study is to see whether injecting local anaesthetic into the vaginal tissues,just prior to transvaginal egg collection,will decrease the amount of pain experienced by women having their eggs collected on an IVF cycle. All women will also receive intravenous sedation as required as well as a sleeping tablet thirty minutes prior to the procedure which is our routine procedure for egg collection.
详细描述
Transvaginal oocyte retrieval is the most common method of oocyte collection in IVF cycles. A variety of different methods are used to provide analgesia/anesthesia for oocyte collection. Our unit has always used an oral pre-medication followed by intravenous fentanyl during the procedure but this doesn't seem to provide adequate analgesia for some women. The aim of this study was to compare the addition of intravaginal local anaesthetic injection versus saline placebo to our usual analgesia regime to see whether less intravenous fentanyl was required and whether the women experienced less pain during oocyte collection.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •About to undergo transvaginal oocyte retrieval
排除标准
- •Already undergone oocyte retrieval and participated in study (i.e. 2nd or more oocyte collection procedure during study period)
- •Allergy to lignocaine
- •Oocytes only to be collected from one ovary
- •Procedure expected to be exceptionally painful
研究组 & 干预措施
LA
Intravaginal and pre-peritoneal injection of 1% lignocaine into each side of the upper vagina under ultrasound guidance immediately prior to ultrasound guided transvaginal oocyte retrieval
干预措施: lignocaine (Drug)
P
Intravaginal saline placebo injection into each side of upper vagina under ultrasound guidance immediately prior to transvaginal oocyte retrieval
干预措施: normal saline (Drug)
结局指标
主要结局
Total dose of iv fentanyl used during oocyte collection
时间窗: Length of oocyte collection (minutes)
次要结局
- Pregnancy outcome(7 weeks gestation)
- Pain score (cm on a Visual Analogue Scale) at 6 different points during oocyte collection(Actual point in time)
- Length of oocyte collection procedure(Time taken (minutes))
- Occurence of nausea or vomiting(During oocyte collection procedure)
- Administration of atropine or anti -emetic(During oocyte collection procedure)
- Time spent in recovery room(Time from end of oocyte collection until discharge home)
- No of oocytes collected(During oocyte collection procedure)
- Number of oocytes fertilised(Assessed 18 hours after oocyte collection)
- Number of embryos frozen(Within 6 days of oocyte collection)
- Pulse rate at beginning and end of egg collection(Point in time)
- Maximum pulse rate during oocyte collection(Point in time during oocyte collection procedure)