Evaluating pain relief during hemorrhoid treatment with radiofrequency
Evaluation of the Value of Perianal Infiltration During Thermodestruction of Haemorrhoidal Disease by Radiofrequency
This study is testing if using a local anesthetic during a specific hemorrhoid treatment can help reduce pain and improve recovery for patients.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Departemental Vendee Academic / other |
| Locations | 3 sites (La Roche sur Yon and 2 other locations) |
| Trial ID | NCT05519189 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of perianal infiltration of ropivacaine during the radiofrequency thermodestruction procedure for treating internal hemorrhoids. The study aims to assess whether this local anesthetic can reduce postoperative pain and complications associated with traditional surgical methods. Patients scheduled for the RAFAELO® procedure will be enrolled, and their outcomes will be compared based on the presence or absence of the infiltration. The trial is designed to provide insights into improving patient comfort and recovery during hemorrhoidal disease treatment.
Who should consider this trial
Good fit: Ideal candidates are adults scheduled for hemorrhoidal thermodestruction surgery who can provide informed consent.
Not a fit: Patients under 18, those with previous hemorrhoid surgeries, or those with hypersensitivity to local anesthetics may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative pain and complications for patients undergoing hemorrhoid treatment.
How similar studies have performed: Other studies have shown promising results with local anesthetic infiltration in surgical procedures, suggesting potential benefits in this context as well.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
La Roche sur Yon and 2 other locations
- Centre Hospitalier Départemental Vendée — La Roche sur Yon, France (Recruiting)
- Centre Hospitalier Universitaire de Nantes — Nantes, France (Not_yet_recruiting)
- Clinique Mutualiste de l'Estuaire — Saint-Nazaire, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Emeric ABET — Centre Hospitalier Départemental Vendée
- Study coordinator: Chloé MOREAU
- Email: chloe.moreau@ght85.fr
- Phone: 251446327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.