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COMPLETED
NCT07688031
PHASE4

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

Sponsor: Pontificia Universidad Catolica de Chile

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

Official title: Efficacy and Safety of Topical Lidocaine 23%/Tetracaine 7% Ointment Versus Placebo for Post-Hemorrhoidectomy Pain: A Double-Blind Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

74

Start Date

2023-05-24

Completion Date

2026-05-12

Last Updated

2026-07-07

Healthy Volunteers

No

Interventions

DRUG

Lidocaine 23% / Tetracaine 7% topical ointment (compounded)

Compounded topical ointment containing lidocaine 23% and tetracaine 7%, prepared by an independent compounding pharmacy. Approximately 2 g applied to the perianal area every 12 hours from postoperative day 0 through day 10.

OTHER

Placebo ointment

Inert topical ointment identical in appearance, color, texture, and packaging to the active intervention, prepared by the same independent compounding pharmacy. Applied following the same schedule as the active ointment

Locations (1)

Red UC Christus Hospital

Santiago, RM, Chile