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.

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

Study Overview

• Status: Completed
• Conditions: Cancer of Prostate

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Mexico
  • Aztcapotzalco
    • Mexico City, Aztcapotzalco, Mexico, 07300
      • Edgar Beltran-Suarez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Instituto Mexicano del Seguro Social
• Investigators: Principal Investigator: EDGAR BELTRAN-SUAREZ, MD, HOSPITAL OF SPECIALTIES OF THE NATIONAL MEDICAL

Publications and helpful links

General Publications

• 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.

Helpful 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:

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): July 31, 2017

Study Registration Dates

• First Submitted: February 10, 2018
• First Submitted That Met QC Criteria: February 15, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): March 27, 2018
• Last Update Submitted That Met QC Criteria: March 25, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Cancer of Prostate; Analgesic method
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: R-2017-3501-61

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No