Could skipping a needle stick make hemorrhoid treatment easier?
NCT ID NCT05519189
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 Hide 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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Genom att skicka in godkänner du våra Användarvillkor
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
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Centre Hospitalier Universitaire de Nantes
Nantes, France
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Clinique Mutualiste de l'Estuaire
Saint-Nazaire, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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