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

NCT03442075 | Completed

• 1 other identifier: R-2017-3501-61
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer of Prostate

Keywords

Cancer of Prostate; Analgesic method

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Biopsy

  Interview 15 to 30 minutes at the end of the procedure

Other Outcomes (1)

• General procedure

  Interview 15 to 30 minutes at the end of the procedure

Study Arms (5)

Group 1

Group 1 an analgesic suppository was applied

Group 2

Group 2 was administered analgesic orally

Group 3

Group 3 was given trans rectal gel

Group 4

Group was performed peri prostatic infiltration.

Group 5

Group was performed by placebo oral

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients from the consultation were taken from the first time they were derived from the peripheral clinics or from the ones derived from our same medicine, with suspicion of prostate cancer and that the criteria for carrying out the trans rectal prostate biopsy were met.

You may qualify if:

• Male patients older than 18 years with indication for trans rectal prostate biopsy

You may not qualify if:

• Bad intestinal preparation.
• Painful anorectal pathologies.
• Clotting disorders without previous assessment by hematology.
• Acute prostatitis

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Edgar Beltran-Suarez

Mexico City, Aztcapotzalco, 07300, Mexico

Location

Related Publications (6)

• 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.

  PMID: 26074382 BACKGROUND

• 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.

  PMID: 26498056 BACKGROUND

• 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.

  PMID: 23787356 BACKGROUND

• 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.

  PMID: 21757258 BACKGROUND

• 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.

  PMID: 16800136 BACKGROUND

• 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.

  PMID: 26229322 BACKGROUND

Related Links

• 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:

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• EDGAR BELTRAN-SUAREZ, MD

  HOSPITAL OF SPECIALTIES OF THE NATIONAL MEDICAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Edgar Beltran-Suarez

Study Record Dates

• First Submitted: February 10, 2018
• First Posted: February 22, 2018
• Study Start: May 1, 2017
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: March 27, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)