Pain Comparison Whit Visual Analog Scale (EVA) Between Four Analgesic Methods During Trans Rectal Prostatic Biopsy
NCT ID: NCT03442075
Last Updated: 2018-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
70 participants
OBSERVATIONAL
2017-05-01
2017-07-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Group 1
Group 1 an analgesic suppository was applied
No interventions assigned to this group
Group 2
Group 2 was administered analgesic orally
No interventions assigned to this group
Group 3
Group 3 was given trans rectal gel
No interventions assigned to this group
Group 4
Group was performed peri prostatic infiltration.
No interventions assigned to this group
Group 5
Group was performed by placebo oral
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Painful anorectal pathologies.
* Clotting disorders without previous assessment by hematology.
* Acute prostatitis
18 Years
75 Years
MALE
No
Sponsors
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Instituto Mexicano del Seguro Social
OTHER_GOV
Responsible Party
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EDGAR BELTRAN-SUAREZ
Dr Edgar Beltran-Suarez
Principal Investigators
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EDGAR BELTRAN-SUAREZ, MD
Role: PRINCIPAL_INVESTIGATOR
HOSPITAL OF SPECIALTIES OF THE NATIONAL MEDICAL
Locations
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Edgar Beltran-Suarez
Mexico City, Aztcapotzalco, Mexico
Countries
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References
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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.
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.
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.
Related Links
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National Cancer Institute. A Snapshot of Prostate Cancer: Incidence and Mortality
WHO \| GLOBOCAN 2012 Estimated Cancer Incidence, Mortality and Prevalence Worlwide in 2012 \[Internet\]. 2015 \[cited 2016 Mar 21\]. p. 3. Available from:
Other Identifiers
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R-2017-3501-61
Identifier Type: -
Identifier Source: org_study_id
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