Intracervical Lidocaine Versus Intramuscular Diclofenac for Pain Relief in HSG in a Tertiary Hospital in Kano
2016年9月27日 更新者：Sulaiman Muhammaad Daneji、Bayero University Kano, Nigeria
The Effect of Intracervical Lidocaine Versus Intramuscular Diclofenac for Pain Relief During Hysterosalpingography Among Infertile Women In A Tertiary Hospital In Kano: A Randomized Controlled Trial
This study compares the effect of intracervical block with 1% lidocaine and intramuscular diclofenac 75mg in decreasing pain perception during hysterosalpingography.
Half of participants will receive intracervical block with 1% lidocaine, while the other half will receive intramuscular diclofenac 75mg.
研究概览
详细说明
Hysterosalpingography (HSG) is a radiographic test to evaluate the contour of the uterine cavity and patency of the fallopian tubes after injection of a radio-opaque dye through the cervix. It is typically performed in the evaluation of infertility or to diagnose uterine anomalies. It is the most common method of tubal evaluation in the developing countries because it is cheap, readily available and requires less expertise. Unfortunately, HSG can cause discomfort or pain for the patient during or after the procedure, and this evokes anxiety and fear for many patients. Up to 72 % of women complain of significant discomfort with this test.
Lidocaine is a local anaesthetic which exerts its effect by altering neuronal depolarization by blocking the sodium channels in the cell membrane, thereby preventing transmission of the sensation of pain to the higher neurons. Lidocaine is commonly used for infiltration and for peripheral nerve blocks if an intermediate duration is required.
Diclofenac is a Non-steroidal anti inflammatory drug that reduce nociception which is related to inflammation and inflammatory mediators whether from trauma
研究类型
介入性
注册 (预期的)
140
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Sulaiman D Muhammad, MBBS
- 电话号码：+238065305050
- 邮箱：smuhddane@yahoo.com
学习地点
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Kano State
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Kano、Kano State、尼日利亚
- 招聘中
- Aminu Kano Teaching Hospital
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接触：
- Sulaiman D Muhammad, MBBS
- 电话号码：+2348065305050
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首席研究员：
- Sulaiman D Muhammad, MBBS
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 49年 (成人)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- All women with infertility who will be undergoing a hysterosalpingography, and must have given consent will be recruited into the study
Exclusion Criteria:
- History of any allergies to local anaesthetics, radio-opaque dye, or anti-inflammatory medications
- All patients with active pelvic inflammatory diseases
- All patients with chronic pelvic pain
- Patients with history of cervical surgery
- Other indications for hysterosalpingography like Ashermans syndrome, congenital uterine anomalies
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Intracervical lidocaine
This group will comprise of patients that will receive the intracervical block.
The study group will receive a total of 60 mg (6 mL) of 1% lidocaine to be injected at four points (12, 4, 6, and 8 o'clock) circumferentially into the cervix (1.5 mL at each point) 5 minutes before proceeding with the hysterosalpingogram.
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Intracervical lidocaine injected at four different points
其他名称：
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有源比较器：Intramuscular Diclofenac
This group will comprise of patients that will receive intramuscular diclofenac potassium 75mg 30 minutes before proceeding with the hysterosalpingogram.
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Intramuscular Diclofenac 30 mins before HSG
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Visual Analogue Score
大体时间：Preprocedure and procedure time 0
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A detailed description of the visual analogue scale (VAS) will be given personally to each woman prior to the procedure.
The VAS included a 10 cm linear scale on which 0 represents 'no pain' and 10 represents 'worst pain imaginable'.
All patients will be asked to grade their perceived lower abdominal pain levels during specified stages of HSG using the VAS as explained to them.
The scale will be used at different stages of the procedure: (1) before beginning the procedure; (2) after speculum application but before instrumentation; (3) after the application of the tenaculum and metal cannula and just before the injection of contrast medium; (4) at the end of uterine filling with contrast medium;
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Preprocedure and procedure time 0
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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patient's satisfaction with pain relief in the two groups using Likert scale
大体时间：Time Frame: 30 minutes post procedure and 24 hours post procedure
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Time Frame: 30 minutes post procedure and 24 hours post procedure
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Change in pain score from pre-procedure to 5 and 30 minutes post procedure
大体时间：5 minutes and 30 minutes
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5 minutes and 30 minutes
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Change in pain score from pre-procedure to 5 and 24 hours post procedure
大体时间：5 minutes and 24 hours
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5 minutes and 24 hours
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Sulaiman D Muhammad, MBBS、Aminu Kano Teaching Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Costello MF, Horrowitz S, Steigrad S, Saif N, Bennett M, Ekangaki A. Transcervical intrauterine topical local anesthetic at hysterosalpingography: a prospective, randomized, double-blind, placebo-controlled trial. Fertil Steril. 2002 Nov;78(5):1116-22. doi: 10.1016/s0015-0282(02)03362-9.
- Hamilton M. Infertilty. In Edmonds K (Editor). Dewhurst's Textbook of obstetrics and gynecology. 8th edition. John Wiley and sons ltd 2012 567-79.
- Hacivelioglu S, Gencer M, Cakir Gungor A, Kosar S, Koc E, Cosar E. Can the addition of a paracervical block to systemic or local analgesics improve the pain perceived by the patient during hysterosalpingography? J Obstet Gynaecol. 2014 Jan;34(1):48-53. doi: 10.3109/01443615.2013.828025.
- Chauhan MB, Lakra P, Jyotsna D, Nanda S, Malhotra V. Pain relief during hysterosalpingography: role of intracervical block. Arch Gynecol Obstet. 2013 Jan;287(1):155-9. doi: 10.1007/s00404-012-2515-z. Epub 2012 Aug 28.
- Robinson RD, Casablanca Y, Pagano KE, Arthur NA, Bates GW, Propst AM. Intracervical block and pain perception during the performance of a hysterosalpingogram: a randomized controlled trial. Obstet Gynecol. 2007 Jan;109(1):89-93. doi: 10.1097/01.AOG.0000247645.52211.41.
- Ahmad G, Duffy J, Watson AJ. Pain relief in hysterosalpingography. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD006106. doi: 10.1002/14651858.CD006106.pub2.
- Sinnatamby CS editor. Last's Anatomy: Regional and Applied. 11th Edition. Edinburgh. Churchill Livingstone; 2006. P 311-6.
- Simpson WL Jr, Beitia LG, Mester J. Hysterosalpingography: a reemerging study. Radiographics. 2006 Mar-Apr;26(2):419-31. doi: 10.1148/rg.262055109.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年9月1日
初级完成 (预期的)
2017年2月1日
研究完成 (预期的)
2017年3月1日
研究注册日期
首次提交
2016年9月25日
首先提交符合 QC 标准的
2016年9月27日
首次发布 (估计)
2016年9月29日
研究记录更新
最后更新发布 (估计)
2016年9月29日
上次提交的符合 QC 标准的更新
2016年9月27日
最后验证
2016年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.