Clinical Trials Directory

Trials / Completed

CompletedNCT03442075

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.

Status
Completed
Phase
Study type
Observational
Enrollment
70 (actual)
Sponsor
Instituto Mexicano del Seguro Social · Other Government
Sex
Male
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

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

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

Conditions

Timeline

Start date
2017-05-01
Primary completion
2017-07-31
Completion
2017-07-31
First posted
2018-02-22
Last updated
2018-03-27

Locations

1 site across 1 country: Mexico

Source: ClinicalTrials.gov record NCT03442075. Inclusion in this directory is not an endorsement.