The Effect of Intrauterine Lidocaine Infusion and Oral Tramadol on Pain During Diagnostic Office Hysteroscopy in Postmenopausal Women: Randomized Double-Blind Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Pain perception during the procedure
研究概览
简要总结
The purpose of this study is to compare the effectiveness of Tramadol and intrauterine lidocaine infusion in reducing pain during outpatient diagnostic hysteroscopy in postmenopausal women.
详细描述
The purpose of this study is to compare the effectiveness of Tramadol and intrauterine lidocaine infusion in reducing pain during outpatient diagnostic hysteroscopy in postmenopausal women. Postmenopausal Women undergoing outpatient hysteroscopy in Cairo university will be divided into three groups, the first group will receive Tramadol 5mg 1 hour before the procedure, the second group will receive 20 ml lidocaine in 1000 ml normal saline infusion during the procedure, and the third will receive a placebo. A visual analog scale will assess 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Menopausal patients with an indication for office hysteroscopy (postmenopausal bleeding or abnormal ultrasound findings)
- •Consent to the procedure
排除标准
- •Positive Chlamydia culture.
- •patients who have an Allergy to local anesthesia or tramadol.
- •A previous adverse reaction to any of the drugs used in the study.
- •Patients were receiving any form of analgesia or current use of monoamine oxidase inhibitors.
- •Nulliparous patients and patients with cervical pathology, retroverted uterus (detected by transvaginal ultrasound), and previous cervical surgery.
- •Patients who have severe vaginal bleeding.
研究组 & 干预措施
lidocaine infusion arm
The lidocaine group will be administered a 1,000 ml distention medium containing 5 ml lidocaine per 250 ml (DEBOCAINE (LIDOCAINE) 2% 1 VIAL 50 ML, Sigma-Tec pharmaceutical Industry. Co. Egypt) and oral placebo similar to tramadol(given 1 hour before the procedure).
干预措施: Lidocaine (Drug)
tramadol arm
will be administered with an oral tramadol tablet (Tramal®, Memphis, Giza, Egypt) 1 h before the procedure and with a 1,000 ml distention medium containing 5 ml serum physiologic per 250 ml.
干预措施: Tramadol (Drug)
placebo group
will be administered with a 1,000 ml distention medium containing 5 ml serum physiologic per 250 ml and oral placebo(1 h before the procedure).
干预措施: placebo (Drug)
结局指标
主要结局
Pain perception during the procedure
时间窗: 10 minutes after starting the procedure.
The pain will be assessed using a visual analogue scale(VAS) after inserting the hysteroscope through the cervical canal.VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced pain. The pain VAS is self-completed by the patients. The patients are asked to place a line perpendicular to the VAS line at the point that represents their pain intensity
次要结局
- Pain perception after the procedure(10 minutes after the procedure.)
研究者
Ahmed Samy aly ashour
lecturer in obstetrics and gynecology
Cairo University