Acmella Oleracea in the Analgesia of the Digital Rectal Examination

Study Overview
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Brief Summary
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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
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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.

Official Title
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Acmella Oleracea in the Analgesia of the Digital Rectal Examination

Conditions
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Analgesia in the Digital Rectal Examination

Intervention / Treatment
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* Biological: Acmella oleracea gel
* Drug: Lidocaine 2 % Topical Cream
* Other: Ultrasound gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acmella oleracea gel group<br>Formulation with Acmella oleracea will be used during the digital rectal examination. | Biological: Acmella oleracea gel<br>* Study group will use Acmella oleracea gel during the digital rectal examination.<br>|
| Active Comparator: Lidocaina gel group<br>The lidocaine gel will be used during the digital rectal examination. | Drug: Lidocaine 2 % Topical Cream<br>* Control group will use lidocaine 2% gel during the digital rectal examination.<br>|
| Placebo Comparator: Ultrasound gel group<br>The ultrasound gel will be used during the digital rectal examination. | Other: Ultrasound gel<br>* Control group will use ultrasound gel during the digital rectal examination.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the pain | 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. | 1 day (After the digital rectal examination) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostatic neoplasms, Digital Rectal Examination, Phytotherapy, Pain, Analgesia, Spilanthes oleracea