Efficacy of Local Lidocaine Gel for Pain Management During Transrectal Sonography in Virgins With Suspected Pelvic Pathology, A Phase II Single Arm Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Decrease the intensity of pain associated with lidocaine gel during trans-rectal ultrasound in compraison with patients exepectaions before the TRU examination by using Visual Analogue Scale, which is one of the valided pain rating scales.
研究概览
简要总结
Ultrasound is a very useful diagnostic tool in the obstetrics and gynecologic field. It is used to diagnose pelvic organs including the uterus, ovaries, tubes and endometrium, and can be used to evaluate gynecologic tumors regardless of their risk of malignant index. The types of pelvic sonography according to route include transvaginal sonography (TVS), transabdominal sonography (TAS), and transrectal sonography (TRS). Insertion of the probe into the vagina allows a very close and clear view of the pelvic organs, physicians have preferred TVS to TAS for accurate diagnosis of pelvic pathology .
详细描述
TVS is not acceptable because of a virginal introitus, agenesis of the vagina, or patient refusal of the introduction of a probe into the vagina, TRS may be a useful alternative tool for evaluating pelvic organs. The rectal administration of a local anesthetic, lidocaine gel, was recently proposed to reduce the pain of TRS-guided biopsy of the prostate. A similar result was also shown in a study evaluating the efficacy of lidocaine gel in rigid cystoscopy. However, data on the efficacy of lidocaine gel on providing the pain relief during TRS in gynecologic patients are lacking. Considering the clinical situation that many women have hesitated to undergo TRS because of concerns about pain, studies investigating methods for relieving pain during TRS are needed.
Recently, there are different type of scale, that are used for assessing pain but without any valid (accurate) and reliable (reproducible) instruments it is difficult to have real effect of treatment. The most commonly used pain scales are the Visual Analogue Scale (VAS), the Numerical Rating Scale (NRS) the Verbal Rating Scale (VRS) .
VAS is used in epidemiological and clinical research to calculate the intensity and frequency of a variety of clinical symptoms. In randomized controlled trials (RCT) and clinical trials (CT) VAS is frequently used to determine the effectiveness of treatment as an outcome measure. VAS is also very much popular in the gynecological area. In post operative pain assessment this scale is applied to measure pain. Moreover, after caesarean section the VAS is used to assessing pain
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with undiagnosed acute pelvic pain
- •Patients with undiagnosed abnormal uterine bleeding
- •Parents consent for patients less than 18 years
排除标准
- •Medical history of allergy to lidocaine
- •Chronic pelvic pain
- •Chronic pain condition for which patients were taking daily pain medication
- •Anorectal pathologies
结局指标
主要结局
Decrease the intensity of pain associated with lidocaine gel during trans-rectal ultrasound in compraison with patients exepectaions before the TRU examination by using Visual Analogue Scale, which is one of the valided pain rating scales.
时间窗: 3 months
A Visual Analogue Scale is one of the valided pain rating scales used for the first time in 1921 by Hayes and Patterson.
次要结局
未报告次要终点
研究者
Ahmed Sewidan
lecturer
Suez University
