Acmella Oleracea in the Analgesia of the Digital Rectal Examination

Universidade do Vale do Sapucai

Status and phase: Completed; Phase 1

Conditions: Analgesia in the Digital Rectal Examination

Treatments: Drug: Lidocaine 2 % Topical Cream; Biological: Acmella oleracea gel; Other: Ultrasound gel

Study type: Interventional

Funder types: Other

Identifiers

NCT05141864

Acmella

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: Male

Ages: 45 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups, including a placebo group

Acmella oleracea gel group

Active Comparator group

Description:

Formulation with Acmella oleracea will be used during the digital rectal examination.

Treatment:

Biological: Acmella oleracea gel

Lidocaina gel group

Active Comparator group

Description:

The lidocaine gel will be used during the digital rectal examination.

Treatment:

Drug: Lidocaine 2 % Topical Cream

Ultrasound gel group

Placebo Comparator group

Description:

The ultrasound gel will be used during the digital rectal examination.

Treatment:

Other: Ultrasound gel