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

NCT07688031 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-07-07

No results posted yet for this study

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

Conditions

  • Pain Management
  • Hemorrhoids Third Degree
  • Hemorrhoids Fourth Degree
  • Hemorrhoids Second Degree

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

Sponsors & Collaborators

  • Sociedad Chilena de Coloproctología

    collaborator UNKNOWN

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-24
Primary Completion
2025-10-09
Completion
2026-05-12

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07688031 on ClinicalTrials.gov