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Completed NCT07688031

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

Conditions: Pain Management, Hemorrhoids Third Degree, Hemorrhoids Fourth Degree, Hemorrhoids Second Degree

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 74
Sponsor: Pontificia Universidad Catolica de Chile

Location: Red UC Christus Hospital Santiago RM

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

Eligibility Criteria

Inclusion Criteria: * Age 18 years or older * Scheduled for elective hemorrhoidectomy * Recruited consecutively on the day of surgery * Able to provide written informed consent Exclusion Criteria: * Inflammatory bowel disease * Immunosuppression * Pregnancy * Chronic pain requiring ongoing analgesic treatment * Known hypersensitivity to any of the study medications * Significant cardiovascular disease * Peripheral vascular disease * Cerebrovascular disease * Hepatic disease * Seizure disorders

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07688031). StuddyBuddy aggregates publicly available trial information.