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