In short
There is currently 1 ongoing clinical trial exploring new approaches to managing haemorrhoids. This trial is testing the use of ropivacaine, a local anaesthetic medication, to help reduce pain following a radiofrequency treatment procedure for haemorrhoids. The study is being conducted in France and aims to improve comfort and recovery for patients undergoing this minimally invasive treatment.
Clinical trial locations
Study on Pain Relief for Hemorrhoids Using Ropivacaine and Ropivacaine Hydrochloride in Patients Undergoing Radiofrequency Treatment
This clinical trial is investigating whether using ropivacaine can help reduce pain after a specific treatment for haemorrhoids. The study focuses on patients undergoing the RAFAELO® procedure, which uses radiofrequency energy (heat) to shrink haemorrhoids. This is a minimally invasive approach that aims to treat the condition with less discomfort than traditional surgery.
Inclusion criteria: To participate in this study, patients must be over 18 years old and scheduled to undergo the RAFAELO® procedure for their haemorrhoids. Participants need to be able to understand what the study involves and must provide written consent to take part. They also need to be affiliated with the social security system or be an entitled beneficiary, meaning they have access to social security benefits.
Exclusion criteria: The study cannot include individuals who fall outside the specified age range, those who have medical conditions other than haemorrhoidal disease, or people who are considered part of a vulnerable population requiring special protection. Additionally, individuals who do not meet the specific health requirements set by the study will be excluded.
Main focus and goal: The primary aim of this trial is to evaluate whether injecting ropivacaine around the anal area can help manage pain after the RAFAELO® procedure. Ropivacaine is a local anaesthetic that numbs a specific area of the body, and its effects typically last between six to twelve hours. Researchers will monitor participants' pain levels six hours after the procedure to determine if ropivacaine provides meaningful pain relief compared to a placebo. The study will help doctors understand if this medication can improve comfort and recovery for patients undergoing radiofrequency treatment for haemorrhoids.
Investigational treatment: The trial is testing ropivacaine, administered through injection, in combination with the RAFAELO® procedure. While the RAFAELO® procedure itself uses radiofrequency energy to treat the haemorrhoids, the focus of this study is specifically on whether adding ropivacaine can enhance pain management during the recovery period.
Summary
Currently, there is one active clinical trial exploring pain management strategies for patients with haemorrhoids. This trial is taking place in France and focuses on the use of ropivacaine as a pain relief measure following radiofrequency treatment. The study represents an effort to improve patient comfort and recovery outcomes for those undergoing the RAFAELO® procedure, a minimally invasive treatment option for haemorrhoidal disease. Patients interested in participating should meet the specified criteria and be prepared to undergo monitoring of their pain levels following the procedure.
