Effectiveness of Paracervical Block Versus Lidocaine Spray During Endometrial Biopsy Under Oral Analgesic Drugs; A Randomized Controlled Trial
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
- Effectiveness of paracervical block VS Lidocaine spray during endometrial biopsy ; A randomized controlled trial
研究概览
简要总结
The purpose of this study to determine effectiveness of paracervical block, lidocaine spray and only oral analgesic drugs for pain relief during endometrial biopsy.
详细描述
Participants : This study was conducted prospectively at the outpatient clinic, Department of Obstetrics and Gynecology, Songklanagarind Hospital.
Inclusion criteria : The women who had abnormal uterine bleeding and indication for endometrial biopsy were enrolled.
Exclusion criteria : included 1) contraindications to NSAID or Lidocaine - known sensitivity to these drugs; 2) pregnancy; 3) genital tract infection; 4) coagulation disorder; and 5) unstable vital signs.
Sample size calculation : Sample size was calculated by assuming the different mean pain score of each groups performing the endometrial biopsy to be 1. To evidence this difference with a power of 80% and a 5% level of significance, a need was calculated with 36 women in each group and for total was 108 women.
Z α/2 = Type I error(alpha error) α = 0.05 >> 1.96 Z β = Type II error(beta error) β = 0.2 >> 0.84
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
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •abnormal uterine bleeding women
- •indicated for endometrial biopsy
排除标准
- •contraindications to NSAID or Lidocaine - known sensitivity to these drugs
- •genital tract infection
- •coagulation disorder
- •unstable vital signs.
研究组 & 干预措施
paracervical block with 1%lidocaine and 0.9%NSS spray(placebo)
first groups receive paracervical block with 1%lidocaine and 0.9%NSS spray(placebo)
干预措施: paracervical block with 1%lidocaine (Drug)
10%lidocaine spray and paracervical block with 0.9%NSS
the second groups receive 10%lidocaine spray and paracervical block with 0.9%NSS(placebo)
干预措施: 10%lidocaine spray (Drug)
receive placebo both paracervical block and spray
the third groups receive placebo both paracervical block and spray
干预措施: paracervical block with 1%lidocaine (Drug)
receive placebo both paracervical block and spray
the third groups receive placebo both paracervical block and spray
干预措施: 10%lidocaine spray (Drug)
结局指标
主要结局
Effectiveness of paracervical block VS Lidocaine spray during endometrial biopsy ; A randomized controlled trial
时间窗: up to 12 months
measurement outcome by record Pain score(NRS)\[Numberical rating scale 0-10\] immediately after procedure and 15 minutes after procedure in all groups Group 1(1%Lidocaine) Group 2(10%Lidocaine spray) Group 3 Control group(Placebo) Pain score immediately and Pain score 15 minutes were compared between group by using statistic analysis to indentify the significant of decreasing Pain score for pain relief during endometrial biopsy. And after that the result will used to determine effectiveness of each groups\[ paracervical block, lidocaine spray and only oral analgesic drugs.
次要结局
- adverse effects of paracervical block versus lidocaine spray(up to 12 months)
研究者
Akarawit Jitchanwichai
faculty of medicine obstertic and gynecology
Mahidol University