AzTrials
AzTrials

HemorrhoidsPhase 4RAFAELOCALNCT05519189

Evaluation of the Value of Perianal Infiltration During Thermodestruction of Haemorrhoidal Disease by Radiofrequency

A Phase 4 study testing Ropivacaine and No peri-anal ropivacaine infiltration in people with Hemorrhoids, run by Centre Hospitalier Departemental Vendee at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Haemorrhoidal disease is a common and benign condition (1). Anatomically, there is an external and internal component. Only internal haemorrhoidal disease is managed by radiofrequency. Different levels of severity of internal haemorrhoidal disease have been defined by the Goligher classification (1). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hemorrhoids
What is being tested?
Ropivacaine and No peri-anal ropivacaine infiltration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
3 sitesFrance
Study dates
10 Jan 2023to 15 Jan 2026
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

France3 sites
  • Centre Hospitalier Départemental Vendée

    La Roche-sur-Yon

  • Centre Hospitalier Universitaire de Nantes

    Nantes

  • Clinique Mutualiste de l'Estuaire

    Saint-Nazaire

Other trials in France

About this study

Haemorrhoidal disease is a common and benign condition (1). Anatomically, there is an external and internal component. Only internal haemorrhoidal disease is managed by radiofrequency. Different levels of severity of internal haemorrhoidal disease have been defined by the Goligher classification (1). According to the recommendations for clinical practice established by the French National Society of ColoProctology (SNFCP), grade I and II haemorrhoidal disease should be managed instrumentally after failure of medical treatment. Grade III and IV haemorrhoidal disease is an indication for surgical management in the first instance or after failure of instrumental treatments. The standard technique is the Milligan and Morgan procedure (pedicle haemorrhoidectomy) described in 1937 (2). This technique consists of the removal of the 3 internal haemorrhoidal bundles. It remains the most effective but is responsible for postoperative complications, in particular pain, haemorrhage, anal strictures and anal incontinence (3), (4). Less aggressive techniques have been developed (Longo technique, HAL-RAR technique). The Longo technique is a circular stapling haemorrhoidopexy. The haemorrhoidal packets are brought up into the anal canal with the help of a circular aggravating forceps removing a collar of rectal mucosa. This removal of the mucosa also allows the vascularisation of the haemorrhoidal venous network to be interrupted. The HAL- RAR technique is a non-resection technique consisting of arterial ligation of the haemorrhoidal packets in order to interrupt the vascularisation supplying the haemorrhoidal packets. This technique can be performed with or without Doppler guidance. Recently, Renshaw et al. described a technique for coagulation of haemorrhoidal bundles using a radiofrequency probe (5).

This technique has shown satisfactory results and is an interesting option in the management of haemorrhoidal disease (6) with low postoperative pain (7).

Read more

In order to limit patients' postoperative pain and reduce their apprehension during defecation episodes, a perianal block has been shown to reduce postoperative pain in patients with a haemorrhoidectomy technique (8,9). In 2019, a prospective randomised trial (10) confirmed the value of this perianal block without a neurostimulator during a haemorrhoidal pack resection procedure. A perianal infiltration of 40 ml of 0.5% Ropivacaine was performed. These 40ml were divided into 4 injections of 10ml each in the left and right antero-lateral position and in the left and right postero-lateral position in relation to the anal margin.

The hemorrhoidal pack resection technique is known to induce postoperative pain. Haemorrhoidal radiofrequency (RAFAELO® procedure) is a new minimally invasive technique that reduces postoperative pain and is usually performed on an outpatient basis (6). Currently, peri-anal infiltration is routinely performed for all haemorrhoidal surgery whether or not there is a haemorrhoidal resection. No studies have evaluated the relevance of maintaining peri-anal infiltration in non-resected haemorrhoidal surgery and in particular during radiofrequency haemorrhoidal packets. In addition, ropivacaine infiltration is not without risks. Local anaesthesia has potential risks for the patient:

  • Adverse reaction or hypersensitivity to local anaesthetics and components
  • Infection at the injection site or infiltration
  • Haematoma at the injection or infiltration site The aim of our study is to demonstrate the non-inferiority of discontinuing perianal infiltration in patients with thermodestructive haemorrhoidal surgery.
Conditions
Hemorrhoids
Being tested
Ropivacaine, No peri-anal ropivacaine infiltration
Medical subject headings
Hemorrhoids

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RopivacaineDrug

    Peri-anal infiltration of Ropivacaine

  • No peri-anal ropivacaine infiltrationOther

    No peri-anal ropivacaine infiltration

Study groups in NCT05519189
Study groupRoleWhat they receive
Peri-anal infiltration of RopivacaineActive comparatorNot described
Receives: Drug: Ropivacaine
No peri-anal ropivacaine infiltrationExperimentalNot described
Receives: Other: No peri-anal ropivacaine infiltration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analogue Scale (VAS) of Pain

    Minimum value = 0 Maximum value = 10

    Measured: H6 post-op (6 hours after the start of the operation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2022
  2. Study start10 Jan 2023
  3. Primary completion16 Dec 2025
  4. Study completion15 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05519189
Sponsor's protocol ID
CHD21_0121
Acronym
RAFAELOCAL
Status last verified
Oct 2026
First submitted
25 Aug 2022
Last updated
4 Nov 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ropivacaine and No peri-anal ropivacaine infiltration in people with Hemorrhoids, run by Centre Hospitalier Departemental Vendee at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale (VAS) of Pain (time frame: H6 post-op (6 hours after the start of the operation)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in