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Could skipping a needle stick make hemorrhoid treatment easier?

NCT ID NCT05519189

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether numbing the anal area with an injection of ropivacaine is necessary during a newer, less invasive radiofrequency procedure for hemorrhoids. 134 adults having this procedure were randomly assigned to receive the injection or not. The main goal was to see if skipping the injection leads to similar pain levels afterward. If it does, patients could avoid the risks and discomfort of the injection itself.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ropivacaine
What this could lead to
If skipping the injection works as well, patients may avoid the risks and discomfort of an extra needle stick during hemorrhoid treatment.
What could go wrong
This is a small, completed Phase 4 study. The results may not apply to all patients or other pain management approaches.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

134 people

The number who actually took part.

Started

Jan 2023

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Major patient * Patient scheduled to undergo hemorrhoidal thermodestruction surgery (RAFAELO® procedure) * Patient able to understand the protocol and having given written informed consent to participate in the study * Patient affiliated to the social security system or entitled to it Exclusion Criteria: * Patient \< 18 years old * Patient with previous hemorrhoidectomy surgery (LONGO technique) * Patient with previous pexy ligation surgery (HAL-RAR technique) * Patients with known hypersensitivity to local anaesthetics or components * Patient with a long term (\>1 month) analgesic treatment (level II and III) * Patient participating in another interventional clinical research protocol involving a drug or clinical investigation of a medical device * Patient who is pregnant, breastfeeding or able to procreate without contraception * Patient under guardianship, curatorship or deprived of liberty

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Centre Hospitalier Départemental Vendée

    La Roche-sur-Yon, France

  • Centre Hospitalier Universitaire de Nantes

    Nantes, France

  • Clinique Mutualiste de l'Estuaire

    Saint-Nazaire, France

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