Acmella Oleracea in the Analgesia of the Digital Rectal Examination

Phase 1

Completed

• Conditions: Analgesia in the Digital Rectal Examination
• Interventions: Drug: Lidocaine 2 % Topical Cream; Biological: Acmella oleracea gel; Other: Ultrasound gel

• Registration Number: NCT05141864
• Lead Sponsor: Universidade do Vale do Sapucai

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.

Study Timeline

• Study Start: 2021-03-05
• Primary Completion: 2021-06-05
• Status Verified: 2021-11
• Study Completion: 2021-11-05
• Study First Submitted: 2021-11-20
• Study First Submitted QC: 2021-12-01
• Last Update Submitted: 2021-12-01
• Study First Posted: 2021-12-02
• Last Update Posted: 2021-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaina gel group	Lidocaine 2 % Topical Cream	The lidocaine gel will be used during the digital rectal examination.
Acmella oleracea gel group	Acmella oleracea gel	Formulation with Acmella oleracea will be used during the digital rectal examination.
Ultrasound gel group	Ultrasound gel	The ultrasound gel will be used during the digital rectal examination.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Universidade do Vale do Sapucaí; 🇧🇷 Pouso Alegre, Minas Gerais, Brazil