Topical Nifedipine 0.3% Plus Lidocaine 1.5% for Uncomplicated Hemorrhoidal Disease
Observational Study on the Use of Topical Nifedipine 0.3% and Lidocaine 1.5% in Acute Uncomplicated Hemorrhoidal Disease
Cardarelli Hospital
80 participants
Sep 2, 2025
OBSERVATIONAL
Conditions
Summary
The goal of this observational study is to evaluate the effectiveness of topical nifedipine 0.3% plus lidocaine 1.5% for uncomplicated hemorrhoidal disease. The main question it aims to answer is: Does topical nifedipine 0.3% plus lidocaine 1.5% lower symptoms in patients with uncomplicated acute hemorrhoidal disease? Participants already taking nifedipine 0.3% plus lidocaine 1.5% as part of their regular medical care for hemorrhoidal disease will undergo four visits over a 30-day period, including two telephone contacts and two in-person visits.
Eligibility
Inclusion Criteria6
- Male and female patients aged 18-75 years.
- Clinical or anoscopic diagnosis of acute hemorrhoidal disease with prolapse severity between Grade II and IV (Goligher), possibly associated with external congestion.
- Patients who started treatment with nifedipine 0.3% + lidocaine 1.5% within the past 5 days.
- Availability of clinical evaluations at treatment initiation (proctologic visit and HDSS, SHS-HD, VAS scales).
- Ability to understand the informed consent.
- Signed informed consent.
Exclusion Criteria8
- Acute hemorrhoidal disease complicated by thrombosis or strangulation.
- Coagulopathies.
- Active neoplastic disease.
- Treatment with anticoagulants and/or chemotherapeutic agents.
- Hypersensitivity to active substances, especially lidocaine (and other amide-type local anesthetics) or excipients.
- Severe hypotensive states or cardiovascular insufficiency.
- Pregnancy or breastfeeding.
- Participation in clinical trials involving investigational drugs.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Transrectal and perianal application of nifedipine 0.3% plus lidocaine 1.5% cream twice daily for at least 21 days in patients with acute, uncomplicated hemorrhoidal disease
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07295886