Clinical Trial

Topical Lidocaine 23%/Tetracaine 7% Ointment for Post-Hemorrhoidectomy Analgesia: A Randomized Controlled Trial

Completed Phase 4
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to learn if a topical ointment containing two local anesthetics (lidocaine 23% and tetracaine 7%) can reduce pain after hemorrhoid surgery in adults. The main questions it aims to answer are: * Does the ointment lower post-defecation pain movements in the first 10 days after surgery? * Does the ointment lower overall daily pain in the 10 days after surgery? * Does the ointment reduce the need for rescue pain medication (tramadol)? Researchers will compare the lidocaine/tetracaine ointment to a placebo (a look-alike ointment that contains no active drug) to see if the active ointment works better to reduce pain after hemorrhoid surgery. Participants will: * Apply the ointment or placebo to the anal area every 12 hours for 10 days after surgery * Rate their pain on a scale from 0 to 10 each day, including pain after bowel movements/defecation * Record how many times they take rescue pain medication each day * Receive check-in calls/mesages from the research team after surgery
Trial Details
NCT Number NCT07688031
Lead Sponsor Pontificia Universidad Catolica de Chile
Collaborators: Sociedad Chilena de Coloproctología
Conditions Pain Management, Hemorrhoids Third Degree, Hemorrhoids Fourth Degree, Hemorrhoids Second Degree
Enrollment 74 participants
Start Date 2023-05-24
Primary Completion 2025-10-09 (estimated)
Study Completion 2026-05-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-07