A Randomised Trial for Postoperative Pain After Rectal Misoprostol or Rectal Hyoscine Administration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
Dilatation of the cervix is necessary before operative hysteroscopic procedures. This dilatation with Hegar dilators has certain difficulties and is associated with pain. Cervical priming with various substances soften the cervix, ease the entry for the operation and decrease complications such as uterine perforation.
The investigators aimed to compare rectally administered "misoprostol" and" hyoscine butyl bromide" with sham protocol.
详细描述
The study is planned as a double blind randomised controlled one centre study. It will take part at a operative gynaecological department of a university hospital. Women who apply to the university clinic who have a medical indication for hysteroscopic surgery will be recruited after informed consent.
Patients included in the study will be allocated to three groups. The intervention arms will be two arms and one sham group. The randomisation will be performed to three groups by a third party who is not involved in the surgical procedures.
Upon initial evaluation, a form evaluating age and other sociodemographic characteristics will be filled out before the scheduled hysteroscopy procedure. After completion of the initial form, rectal tablets will be administered according to the allocated group; two hours previously to the procedure. Hysteroscopy will be under general anaesthesia with a 10 mm hysteroscope during the follicular phase of the menstrual cycle.
During the procedure the duration of the cervical entry and total duration of the operation will be noted. Additionally basal dilatation will be noted.
Two hours after the procedure pain will be documented according to the Visual Analogue Scale which is a ten point scale. A value of "1" indicates "no pain". A value of "10" indicates "excruciating" pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind masking
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Reproductive aged women
- •Women who are scheduled for hysteroscopy for indications of endometrial polyp, submucous myoma or synaechiae
排除标准
- •Women who have undergone hysteroscopy previously
- •women who are in menopause
研究组 & 干预措施
Rectal misoprostol
200 mcg of misoprostol will be administered rectally- 2 hours previously. This intervention will be performed by a third party health professional who will be blinded to the procedure.
干预措施: Misoprostol (Drug)
Rectal hyoscine butyl bromide
10 mg hyoscine butyl bromide administered rectally- 2 hours previously. This intervention will be performed by a third party health professional who will be blinded to the procedure.
干预措施: Hyoscine butyl bromide (Drug)
结局指标
主要结局
Postoperative pain
时间窗: Postoperative 2 hours
Two hours after the procedure "postoperative pain" will be documented according to the Visual Analogue Scale which is a ten point scale. A value of "1" indicates "no pain". A value of "10" indicates "excruciating" pain.
次要结局
- Ease of cervical dilatation(During the surgery)
- Analgesic administration(Postoperative 2 hours)
- Duration of procedure(During the surgery)
- Initial cervical dilatation(During the surgery)