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

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What is this study about?

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.

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 preparation for procedure

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

3 administration of medication

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

4 surgical procedure

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

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 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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Saint Nazaire	St Nazaire	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	10.01.2023

Trial locations

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.

Investigated diseases:

Haemorrhoids

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 ID:

2024-514117-35-00

NCT ID:

NCT05519189

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?