Topical nifedipine 0.3% plus lidocaine 1.5% for uncomplicated hemorrhoids

Observational Study on the Use of Topical Nifedipine 0.3% and Lidocaine 1.5% in Acute Uncomplicated Hemorrhoidal Disease

This will try topical nifedipine 0.3% plus lidocaine 1.5% applied rectally and perianally twice daily to reduce symptoms in adults with uncomplicated acute hemorrhoids.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Cardarelli Hospital (Academic / other)
• Locations: 1 site (Naples)
• Trial ID: NCT07295886 on ClinicalTrials.gov

What this trial studies

This is a prospective, observational, single-center study of patients who are already receiving topical nifedipine 0.3% plus lidocaine 1.5% as part of routine care. Participants will apply the ointment twice daily for at least 21 days and complete four assessments over about 30 days (baseline, day 10 phone call, day 21 in-person visit, day 30 phone call). The primary outcome is change in the Hemorrhoidal Disease Symptom Score (HDSS), with secondary measures including changes in prolapse grade, quality of life, and prevention of thrombosis. Data will be entered into a web-based electronic database by study staff at the Cardarelli Hospital center in Naples, Italy.

Who should consider this trial

Good fit: Adults 18–75 with a clinical or anoscopic diagnosis of acute hemorrhoidal disease (Goligher grade II–IV) who started topical nifedipine 0.3% plus lidocaine 1.5% within the past 5 days and can give informed consent are eligible.

Not a fit: Patients with complicated hemorrhoids (thrombosis or strangulation), coagulopathies, active cancer, on anticoagulants/chemotherapy, severe cardiovascular instability, pregnancy/breastfeeding, or known allergy to lidocaine are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If effective, the topical combination could speed symptom relief, reduce prolapse severity, and lower the need for invasive procedures.

How similar studies have performed: Topical calcium-channel blockers like nifedipine have shown benefit in anal fissures, but evidence specifically for nifedipine plus lidocaine in hemorrhoidal disease is limited and largely based on small or real-world studies.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Naples

• Azienda Ospedaliera "Antonio Cardarelli", Napoli — Naples, Italy (Recruiting)

Study contacts

• Study coordinator: Antonio Brillantino, MD, PhD

Conditions Hemorrhoid Bleeding; Hemorrhoids Prolapse; Hemorrhoid Pain; Hemorrhoid; Topical Administration; nifedipine 0.3% plus lidocaine 1.5%; uncomplicated hemorrhoidal disease; hemorrhoids symptoms