Pain Comparison Whit Visual Analog Scale (EVA) Between Four Analgesic Methods During Trans Rectal Prostatic Biopsy
Prospective, Controlled, Randomized Clinical Trial to Evaluate the Effectiveness of Four Analgesic Methods During Trans Rectal Prostate Biopsy.
研究概览
地位
条件
详细说明
Comparison between four analgesic methods during trans rectal prostatic biopsy.
OBJECTIVE: To define the best analgesic method between the peri-prostatic block, the analgesic suppository, the oral analgesic, the final anesthetic gel, during the trans rectal prostate biopsy determined at the end of the procedure with a visual analogue scale for pain (VAS pain) in a Interview 15 to 30 minutes at the end of the procedure.
METHODS: experimental, retrospective, longitudinal, comparative, during May to July 2017, 350 trans rectal prostate biopsies were performed, all cases were randomly assigned to one of the four study groups. The data analysis will be performed by calculating measures of central tendency and dispersion for quantitative variables and ANOVA test, for qualitative variables Chi square to determine statistical differences between the three moments of pain in the parameters of introduction of the ultrasound transducer, sampling of Prostate of the minimum 12 biopsies and discomfort in general of the procedure
研究类型
注册 (实际的)
联系人和位置
学习地点
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Aztcapotzalco
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Mexico City、Aztcapotzalco、墨西哥、07300
- Edgar Beltran-Suarez
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Male patients older than 18 years with indication for trans rectal prostate biopsy
Exclusion Criteria:
- Bad intestinal preparation.
- Painful anorectal pathologies.
- Clotting disorders without previous assessment by hematology.
- Acute prostatitis
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Group 1
Group 1 an analgesic suppository was applied
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Group 2
Group 2 was administered analgesic orally
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Group 3
Group 3 was given trans rectal gel
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Group 4
Group was performed peri prostatic infiltration.
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Group 5
Group was performed by placebo oral
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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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Ultrasound Transducer
大体时间：Interview 15 to 30 minutes at the end of the procedure
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Evaluation of the discomfort or pain in the introduction of the trans rectal ultrasound transducer determined at the end of the procedure with Visual Analog Scale for Pain, which is a psychometric measuring instrument designed to assess the pain intensity experienced by each patient individually. Was employ for first time in 1921 and referred as a "graphical rating method", which has the characteristic of being able to achieve a rapid classification (statistically measurable and reproducible) of the severity of pain experience. The analogous visual scale used for this study measures from 0-10 the intensity of the pain with a series of "faces" that show the intensity in the pain experimentation with categories like "No pain" approximately 0-1, mild, annoying in number 2, nagging in number 4, distressing in number 6, intense in number 8 and worst possible in number 10. |
Interview 15 to 30 minutes at the end of the procedure
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Biopsy
大体时间：Interview 15 to 30 minutes at the end of the procedure
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Evaluation of the discomfort or pain at the moment of the biopsy, that is, when the needle is inserted to take the samples in a 12-cylinder minimum or as needed, determined at the end of the procedure with Visual Analog Scale for Pain, The analogous visual scale used for this study measures from 0 to 10 the intensity of pain with a series of "faces" that show the intensity in the pain experimentation with categories such as "No pain" approximately 0-1, mild, annoying in number 2, annoying in number 4, distressing in number 6, intense in number 8 and worse in number 10. The analogous visual scale used for this study measures from 0-10 the intensity of the pain with a series of "faces" that show the intensity in the pain experimentation with categories like "No pain" approximately 0-1, mild, annoying in number 2, nagging in number 4, distressing in number 6, intense in number 8 and worst possible in number 10. |
Interview 15 to 30 minutes at the end of the procedure
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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General procedure
大体时间：Interview 15 to 30 minutes at the end of the procedure
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Evaluation of the discomfort or pain at the moment of the biopsy, that is, when the needle is inserted to take the samples in a 12-cylinder minimum or as needed, determined at the end of the procedure with Visual Analog Scale for Pain.
The analogous visual scale used for this study measures from 0 to 10 the intensity of pain with a series of "faces" that show the intensity in the pain experimentation with categories such as "No pain" approximately 0-1, mild, annoying in number 2, annoying in number 4, distressing in number 6, intense in number 8 and worse in number 10.
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Interview 15 to 30 minutes at the end of the procedure
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合作者和调查者
调查人员
- 首席研究员：EDGAR BELTRAN-SUAREZ, MD、HOSPITAL OF SPECIALTIES OF THE NATIONAL MEDICAL
出版物和有用的链接
一般刊物
- Loeb S, Vellekoop A, Ahmed HU, Catto J, Emberton M, Nam R, Rosario DJ, Scattoni V, Lotan Y. Systematic review of complications of prostate biopsy. Eur Urol. 2013 Dec;64(6):876-92. doi: 10.1016/j.eururo.2013.05.049. Epub 2013 Jun 4.
- Attard G, Parker C, Eeles RA, Schroder F, Tomlins SA, Tannock I, Drake CG, de Bono JS. Prostate cancer. Lancet. 2016 Jan 2;387(10013):70-82. doi: 10.1016/S0140-6736(14)61947-4. Epub 2015 Jun 11.
- Lowrance WT, Roth BJ, Kirkby E, Murad MH, Cookson MS. Castration-Resistant Prostate Cancer: AUA Guideline Amendment 2015. J Urol. 2016 May;195(5):1444-1452. doi: 10.1016/j.juro.2015.10.086. Epub 2015 Oct 20.
- Mottet N, Bellmunt J, Bolla M, Joniau S, Mason M, Matveev V, Schmid HP, van der Kwast T, Wiegel T, Zattoni F, Heidenreich A. [EAU guidelines on prostate cancer. Part II: treatment of advanced, relapsing, and castration-resistant prostate cancer]. Actas Urol Esp. 2011 Nov-Dec;35(10):565-79. doi: 10.1016/j.acuro.2011.03.011. Epub 2011 Jul 14. Spanish.
- Herranz Amo F, Diez Cordero JM, Cabello Benavente R. [Evolution of the transrectal ultrasound guided prostatic biopsy technique]. Arch Esp Urol. 2006 May;59(4):385-96. Spanish.
- Sahin A, Ceylan C, Gazel E, Odabas O. Three different anesthesia techniques for a comfortable prostate biopsy. Urol Ann. 2015 Jul-Sep;7(3):339-44. doi: 10.4103/0974-7796.152014.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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前列腺癌的临床试验
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Swansea University完全的
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Scripps Translational Science Institute完全的
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Peking Union Medical College Hospital尚未招聘