Evaluation of Perianal Infiltration with Ropivacaine and Ropivacaine Hydrochloride in Radiofrequency Thermodestruction for Hemorrhoidal Disease

The primary objective of this study is to **compare pain** at six hours post-operation in patients undergoing thermodestruction of **hemorrhoidal disease** using the RAFAELO® procedure. This evaluation is clinically relevant as it aims to assess the effectiveness of perianal infiltration in reducing postoperative pain, which is a significant concern for patient comfort and recovery following hemorrhoidal procedures. The study involves the use of **ropivacaine**, an anesthetic, to potentially enhance pain management during the postoperative period.

The clinical trial focuses on individuals diagnosed with **hemorrhoidal disease** and aims to compare pain levels at six hours post-operation. The study population includes both male and female participants, all of whom are over the age of 18. Participants are scheduled for thermodestructive hemorrhoidal surgery, specifically the RAFAELO® procedure. The trial does not involve a vulnerable population. Participants were selected based on their ability to understand the protocol and provide written informed consent, as well as their affiliation with the social security system or status as an entitled beneficiary. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet or physical activity.

The clinical trial is designed to evaluate the efficacy of **ropivacaine** in reducing pain following thermodestructive hemorrhoidal surgery using the RAFAELO® procedure. This study is a randomized, double-blind, controlled trial, ensuring that neither the participants nor the researchers know which treatment the participants are receiving, thereby minimizing bias. The trial is expected to run from January 10, 2023, to February 10, 2025, with participant involvement lasting for a maximum of one day, corresponding to the duration of the procedure and immediate postoperative period.

Participants will undergo a series of study visits, beginning with an inclusion visit where eligibility is confirmed based on criteria such as age (over 18), scheduled surgery, understanding of the protocol, and consent. The primary endpoint is the assessment of pain using a visual analogue scale (VAS) at six hours post-operation, aligning with the known duration of efficacy for **ropivacaine**. The study does not specify secondary endpoints. Follow-up visits are not detailed, as the primary focus is on the immediate postoperative period.

Participants may be withdrawn from the study if they do not adhere to the protocol, withdraw consent, or experience adverse events that necessitate discontinuation. The trial aims to provide insights into the potential benefits of perianal infiltration with **ropivacaine** during the RAFAELO® procedure, contributing to improved pain management strategies for patients undergoing treatment for hemorrhoidal disease.

The clinical trial involves the use of **ROPIVACAINE**, a **solution for injection**. This experimental medication is administered via **injection** and is classified as an **anaesthetic**. The active substance, **ropivacaine**, is of chemical origin. The maximum daily dose is 10 mg/ml, with a total maximum dose of 10 mg/ml, and the treatment period is limited to one day. The pharmaceutical form is a solution specifically designed for injection, ensuring precise delivery of the active compound. The trial aims to evaluate the efficacy of perianal infiltration during the thermodestruction of hemorrhoidal disease using the RAFAELO® procedure.

In addition to the experimental treatment, the study also utilizes **ROPIVACAINE HYDROCHLORIDE** as a comparator. This substance is also administered as a **solution for injection** and serves as an anaesthetic. The active substance, **ropivacaine hydrochloride**, is chemically derived. Although the maximum daily and total doses are recorded as 0 mg/ml, the treatment period is similarly restricted to one day. The comparator is used to assess the relative effectiveness of the experimental treatment in managing post-operative pain.

Efficacy in this clinical trial will be assessed by evaluating the primary endpoint, which is the level of pain experienced by patients at six hours post-operation (H6) following the RAFAELO® procedure for hemorrhoidal disease. The primary efficacy parameter will be measured using the **Visual Analogue Scale (VAS)**, a validated tool for assessing pain intensity. This timepoint was selected based on the known duration of efficacy of **ropivacaine**, which ranges from 6 to 12 hours, allowing for a meaningful comparison of infiltration efficacy between the two groups. The trial aims to determine whether perianal infiltration with ropivacaine provides a beneficial reduction in pain at this specific postoperative interval.