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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

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

Condition or disease
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


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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prospective, Controlled, Randomized Clinical Trial to Evaluate the Effectiveness of Four Analgesic Methods During Trans Rectal Prostate Biopsy.
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.



Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442075


Locations
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Mexico
Edgar Beltran-Suarez
Mexico City, Aztcapotzalco, Mexico, 07300
Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Investigators
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Principal Investigator: EDGAR BELTRAN-SUAREZ, MD HOSPITAL OF SPECIALTIES OF THE NATIONAL MEDICAL

Additional Information:
Publications:
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Responsible Party: EDGAR BELTRAN-SUAREZ, Dr Edgar Beltran-Suarez, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT03442075     History of Changes
Other Study ID Numbers: R-2017-3501-61
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by EDGAR BELTRAN-SUAREZ, Instituto Mexicano del Seguro Social:
Cancer of Prostate
Analgesic method
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs