Analgesia in the Digital Rectal Examination
Conditions
Keywords
Prostatic neoplasms, Digital Rectal Examination, Phytotherapy, Pain, Analgesia, Spilanthes oleracea
Brief summary
The aim of the study is to develop an herbal gel based on Acmella oleracea and do a comparative analysis to evaluate the intensity of pain during the digital rectal examination comparing to lidocaine gel group and ultrasound gel group.
Detailed description
The aim of the study is to develop an herbal gel based on Acmella oleracea and do a comparative analysis to evaluate the intensity of pain during the digital rectal examination comparing to lidocaine gel group and ultrasound gel group. We are conducting a randomized, controlled, single-blind clinical trial of man undergoing to digital rectal examination, with 150 participants. Will be recruit at the Urologic Clinic of the Samuel Libânio Clinical Hospital and Urologic Clinic CISAMESP in Pouso Alegre. Participants divided into three groups, A. oleracea gel group, lidocaine gel group and ultrasound gel group. The digital rectal examination always performed by the same doctor, on the same position. A visual analogue scale (VAS) will be the standard method to evaluate the pain levels. The VAS will be explained to all patients, 0 = no pain and 10 = the most severe pain.
Interventions
BIOLOGICALAcmella oleracea gel
Study group will use Acmella oleracea gel during the digital rectal examination.
DRUGLidocaine 2 % Topical Cream
Control group will use lidocaine 2% gel during the digital rectal examination.
OTHERUltrasound gel
Control group will use ultrasound gel during the digital rectal examination.
Sponsors
Universidade do Vale do Sapucai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
45 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Male patients * Patients to agree to participate in the study
Exclusion criteria
* Diabetic, chronic kidney disease, with urogenital infections, using an indwelling urinary catheter, with history of anorectal diseases or surgeries, psychiatric patients and who refused to participate in the research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the pain | 1 day (After the digital rectal examination) | A visual analogue scale (VAS) will be the standard method to evaluate the pain levels. The VAS will be explained to all patients, 0 = no pain and 10 = the most severe pain. |
Countries
Brazil
Outcome results
None listed