CompletedPhase 4

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

Chile74 participantsStarted 2023-05-24

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial tested a topical lidocaine 23% and tetracaine 7% ointment specifically for pain after hemorrhoid surgery — since it's a Phase 4 trial and has been completed, has the results data been published, and would this ointment be an option my doctor could consider for my recovery?
2The trial focused on pain right after a bowel movement during the first 10 days post-surgery, which is often the most intense part of recovery — based on what this study found, does this type of numbing ointment actually make a meaningful difference in that specific moment compared to standard pain relief approaches?
3Since this trial enrolled patients with second, third, and fourth degree hemorrhoids, does the severity of my hemorrhoids affect whether this kind of topical anesthetic would be expected to help me, or is it more about the type of surgery performed?
4What pain management plan would my doctor currently recommend after hemorrhoidectomy, and is this lidocaine-tetracaine ointment already being used in practice based on evidence like this trial, or is it still considered experimental in routine care?
5Are there any known side effects or absorption concerns with using a high-concentration numbing ointment like lidocaine 23% and tetracaine 7% on post-surgical tissue that I should weigh before asking about this as part of my recovery plan?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Post-defecatory pain score during the first 10 postoperative days

Timeframe: Postoperative days 1 through 10

Trial details

NCT IDNCT07688031

SponsorPontificia Universidad Catolica de Chile

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-09

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