Pain Comparison Whit Visual Analog Scale (EVA) Between Four Analgesic Methods During Trans Rectal Prostatic Biopsy

Cancer of Prostate Clinical Trial

Official title:

Prospective, Controlled, Randomized Clinical Trial to Evaluate the Effectiveness of Four Analgesic Methods During Trans Rectal Prostate Biopsy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03442075
• Other study ID #: R-2017-3501-61
• Status: Completed
• First received: February 10, 2018
• Last updated: March 25, 2018
• Start date: May 1, 2017
• Est. completion date: July 31, 2017

Study information

• Verified date: March 2018
• Source: Instituto Mexicano del Seguro Social
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Define the best analgesic method between peri prostatic blockage, analgesic suppository, oral analgesic and topic anesthetic gel, during trans rectal prostate biopsy

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Prostate
• Prostatic Neoplasms

Locations

Country	Name	City	State
Mexico	Edgar Beltran-Suarez	Mexico City	Aztcapotzalco

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

References & Publications (6)

Attard G, Parker C, Eeles RA, Schröder 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. Review. — View Citation

Herranz Amo F, Diéz Cordero JM, Cabello Benavente R. [Evolution of the transrectal ultrasound guided prostatic biopsy technique]. Arch Esp Urol. 2006 May;59(4):385-96. Review. Spanish. — View Citation

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. Review. — View Citation

Lowrance WT, Roth BJ, Kirkby E, Murad MH, Cookson MS. Castration-Resistant Prostate Cancer: AUA Guideline Amendment 2015. J Urol. 2016 May;195(5):1444-52. doi: 10.1016/j.juro.2015.10.086. Epub 2015 Oct 20. Review. — View Citation

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. — View Citation

Sahin A, Ceylan C, Gazel E, Odabas Ö. Three different anesthesia techniques for a comfortable prostate biopsy. Urol Ann. 2015 Jul-Sep;7(3):339-44. doi: 10.4103/0974-7796.152014. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	General procedure	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.	Interview 15 to 30 minutes at the end of the procedure
Primary	Ultrasound Transducer	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
Secondary	Biopsy	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

External Links

•   InfoCancer México Cancer en Cifras :Estadísticas de Defunciones [Internet]. InfoCancer Mexico. 2015 [cited 2016 Mar 21]. p. 1.
•   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: