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

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ClinicalTrials.gov Identifier: NCT03442075
Recruitment Status : Completed
First Posted : February 22, 2018
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
EDGAR BELTRAN-SUAREZ, Instituto Mexicano del Seguro Social

Tracking Information
First Submitted Date February 10, 2018
First Posted Date February 22, 2018
Last Update Posted Date March 27, 2018
Actual Study Start Date May 1, 2017
Actual Primary Completion Date July 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 21, 2018)
Ultrasound Transducer [ Time Frame: Interview 15 to 30 minutes at the end of the procedure ]
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.
Original Primary Outcome Measures
 (submitted: February 15, 2018)
Ultrasound Transducer [ Time Frame: Interview 15 to 30 minutes at the end of the procedure ]
Evaluation of the discomfort or pain at introduction of the Transrectal transducer of the ultrasound determined at the end of the procedure with Visual Analog Scale for Pain (VAS Pain)
Change History Complete list of historical versions of study NCT03442075 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 21, 2018)
Biopsy [ Time Frame: Interview 15 to 30 minutes at the end of the 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. 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.
Original Secondary Outcome Measures
 (submitted: February 15, 2018)
Biopsy [ Time Frame: Interview 15 to 30 minutes at the end of the procedure ]
Evaluation of the discomfort or pain at introduction of the needle in the 12 cores taken for complete the biopsy determined at the end of the procedure with Visual Analog Scale for Pain (VAS Pain)
Current Other Pre-specified Outcome Measures
 (submitted: February 21, 2018)
General procedure [ Time Frame: Interview 15 to 30 minutes at the end of the 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.
Original Other Pre-specified Outcome Measures
 (submitted: February 15, 2018)
General procedure [ Time Frame: Interview 15 to 30 minutes at the end of the procedure ]
Evaluation of the discomfort or pain in the entire process of transrectal biopsy of the prostate determined at the end of the procedure with Visual Analog Scale for Pain (VAS Pain)
 
Descriptive Information
Brief Title Pain Comparison Whit Visual Analog Scale (EVA) Between Four Analgesic Methods During Trans Rectal Prostatic Biopsy
Official Title Prospective, Controlled, Randomized Clinical Trial to Evaluate the Effectiveness of Four Analgesic Methods During Trans Rectal Prostate Biopsy.
Brief 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

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Cancer of Prostate
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 15, 2018)
70
Original Actual Enrollment Same as current
Actual Study Completion Date July 31, 2017
Actual Primary Completion Date July 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Mexico
Removed Location Countries  
 
Administrative Information
NCT Number NCT03442075
Other Study ID Numbers R-2017-3501-61
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party EDGAR BELTRAN-SUAREZ, Instituto Mexicano del Seguro Social
Study Sponsor Instituto Mexicano del Seguro Social
Collaborators Not Provided
Investigators
Principal Investigator: EDGAR BELTRAN-SUAREZ, MD HOSPITAL OF SPECIALTIES OF THE NATIONAL MEDICAL
PRS Account Instituto Mexicano del Seguro Social
Verification Date March 2018