Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Pain Relief for Hemorrhoids Using Ropivacaine and Ropivacaine Hydrochloride in Patients Undergoing Radiofrequency Treatment

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for hemorrhoidal disease, a common condition that affects the veins in the lower rectum and anus, often causing discomfort and bleeding. The treatment being tested involves the use of ropivacaine, a medication that is injected to help manage pain. Ropivacaine is a type of anesthetic, which means it is used to numb a specific area of the body to reduce pain during and after medical procedures.

The purpose of this study is to evaluate the effectiveness of ropivacaine when used during a specific procedure called the RAFAELO® procedure, which is a method of treating hemorrhoids using radiofrequency energy. This procedure involves the use of heat to shrink the hemorrhoids, and the study aims to determine if injecting ropivacaine around the anal area can help reduce pain after the procedure. Participants in the study will receive either ropivacaine or a placebo, and their pain levels will be compared to see if the ropivacaine provides any additional benefit.

During the study, participants will undergo the RAFAELO® procedure and will be monitored for their pain levels six hours after the procedure. This time frame is chosen because the effects of ropivacaine typically last between six to twelve hours. The study will help determine if the use of ropivacaine is beneficial in managing pain for patients undergoing this type of hemorrhoid treatment.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed. Participants must be over 18, scheduled for a specific hemorrhoidal surgery, able to understand the protocol, and have given written consent.

  2. Step 2

    Preparation for procedure

    Before the procedure, participants receive information about the surgery and the use of ropivacaine, a medication used to manage pain.

  3. Step 3

    Administration of medication

    Ropivacaine is administered through an injection. This medication helps to manage pain during and after the procedure.

  4. Step 4

    Surgical procedure

    The surgical procedure, known as the RAFAELO® procedure, involves thermodestruction of hemorrhoidal tissue. This is performed to treat hemorrhoidal disease.

  5. Step 5

    Post-operative monitoring

    After the procedure, pain levels are monitored using a visual analogue scale (VAS) at 6 hours post-operation. This is to evaluate the effectiveness of the ropivacaine infiltration.

  6. Step 6

    Follow-up

    Participants may be required to attend follow-up appointments to assess recovery and any long-term effects of the treatment.

Who can join the trial?

4 criteria

  • Patients must be **over 18 years old**.
  • Patients must be **scheduled for a specific type of hemorrhoid surgery** called the RAFAELO® procedure. This is a treatment for hemorrhoids using heat.
  • Patients must be **able to understand the study details** and have given their **written consent** to participate. This means they agree to join the study after understanding what it involves.
  • Patients must be **affiliated with the social security system** or be an **entitled beneficiary**. This means they should have access to social security benefits.

Who cannot join the trial?

4 criteria

  • Individuals who are not within the specified age range for the study.
  • Individuals who have medical conditions other than hemorrhoidal disease.
  • Individuals who are part of a vulnerable population, meaning they might need special protection or care.
  • Individuals who do not meet the specific health requirements set by the study.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Radiofrequency Therapy (RAFAELO® Procedure) is a treatment used in this clinical trial to manage hemorrhoidal disease. It involves using radiofrequency energy to shrink and eliminate hemorrhoids. This procedure is minimally invasive and aims to reduce pain and discomfort associated with hemorrhoids. The trial evaluates the effectiveness of this therapy, particularly focusing on pain relief after the procedure.

What is already known about the treatment

Radiofrequency Ablation (RAFAELO® procedure) – This treatment is administered through a minimally invasive procedure using radiofrequency energy to shrink hemorrhoidal tissue. It is currently being evaluated in clinical trials for its effectiveness in reducing pain after hemorrhoid treatment. The main therapeutic indication is for hemorrhoidal disease, a common condition characterized by swollen veins in the lower rectum and anus. The mechanism of action involves the application of radiofrequency energy, which generates heat to cause controlled tissue damage, leading to the shrinkage of hemorrhoids. It is classified under surgical procedures rather than traditional pharmacological categories.

Investigated diseases

Hemorrhoidal Disease – Hemorrhoidal disease involves swollen and inflamed veins in the rectum and anus, leading to discomfort and bleeding. It can be caused by increased pressure in the lower rectum due to straining during bowel movements, sitting for long periods, or chronic constipation. Symptoms may include itching, irritation, and pain around the anus, as well as swelling and bleeding during bowel movements. The condition can progress from mild discomfort to more severe pain and bleeding if not managed properly. Hemorrhoids can be internal, located inside the rectum, or external, under the skin around the anus. The severity of symptoms often dictates the approach to management and relief.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514117-35-00Estimated enrolment134 patientsSponsorCentre Hospitalier Departemental Vendee

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).