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

I

Instituto Mexicano del Seguro Social

Status

Completed

Conditions

Cancer of Prostate

Study type

Observational

Funder types

Other

Identifiers

NCT03442075
R-2017-3501-61

Details and patient eligibility

About

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

Full 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

Enrollment

70 patients

Sex

Male

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

70 participants in 5 patient groups

Group 1
Description:
Group 1 an analgesic suppository was applied
Group 2
Description:
Group 2 was administered analgesic orally
Group 3
Description:
Group 3 was given trans rectal gel
Group 4
Description:
Group was performed peri prostatic infiltration.
Group 5
Description:
Group was performed by placebo oral

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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