Cairo University Faculty of Medicine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- tolerated hystroscopy
研究概览
简要总结
Single blind randomized controlled study in which 80 patients coming for hystroscopy due to multiple indication as infertility, AUB and missed IUD were assigned for our study. Both Sample size and randomization were done by a computer program. Patients were classified into 2 groups, group 1 study group was subjected to intracervical injection of 5 mi of mepivacaine hydrochloride at position 3 and 9 of the vaginal portion of the cervix, and at least 5 minutes post injection before procedure done. The control group received NSAI injection 15 minutes before procedure and 5 ml of saline was injected in each side of cervix at 3 9 positions. Hystroscopy was done if an abnormality is detected an intervention was done. A descriptive scale of pain was done into mild, moderate or severe (that lead to interruption of the procedures).
详细描述
Procedures:
All patients were subjected to:
- History taking
- Verbal consent to participate in our study
- Patient put in lithotomy position
- Casco speculum was applied exposing the cervix
- Betadine sterilization of the cervix then properly washed with saline as heavy metals of disinfectant may cause irritation with injection
- Multiple toothed volselum was used just to fix cervix
- 3 cartridges of mepivacaine hydrochloride was filled in 10 mi syringe
- Do aspiration to exclude and avoid intravascular injection then infilterate slowly intracervical at both 3 and 9 positions
- Instruments are removed and at least 5 minutes later procedure started.
- Hystroscopy (rigid , 2.9 mm sheath) was introduced gently throw vaginoscopy exploring vagina , cervix and uterine cavity
- Patient was monitored for pain all through the procedure by descriptive scale, mild, moderate and severe. ( moderate who needed to take rest then continue , severe that necessitated interruption of the procedure
- All patients were monitored for signs of vaso vagal attack as sings (low blood pressure and bradycardia) before and if needed during. Occurrence of symptoms as pallor , sweet and fainting
- All patients were monitored post procedure for persistence of colicky pain
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
- Single (Participant)
盲法说明
group 1 will be subjected to intracervical injection of mepicaine hydrochloride 3%iof a local anasthetic as Carbocaine3% and group 2 will be subjected to intracervical injection of 5 ml of normal saline
入排标准
- 年龄范围
- — 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •must be under 40 years
- •must be no history of renal or hepatic disease
- •must be no known hypersensitivity to local anaesthetic agents
- •must be no significant vaginal or cervical infection.
排除标准
- •All patients with history of sever vasovagal attack during any gynecological procedures.
结局指标
主要结局
tolerated hystroscopy
时间窗: 30 minutes
complete hystroscopy procedure with tolerable degree of pain.
次要结局
- occurrence of complication(30 minutes)
研究者
Olfat Nooh Riad Ali
professor in cairo univerity
Cairo University