Nitroglycerin Ointment for Pain Relief After Endoscopic Hemorrhoid Band Ligation (NCT07391501) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Nitroglycerin Ointment for Pain Relief After Endoscopic Hemorrhoid Band Ligation
68 participantsStarted 2026-02-01
Plain-language summary
This study is designed to evaluate whether nitroglycerin ointment can reduce pain after endoscopic rubber band ligation for internal hemorrhoids. Endoscopic rubber band ligation is a commonly used, minimally invasive treatment for internal hemorrhoids, but postoperative anal pain is a frequent and sometimes severe complication that can affect daily activities and recovery.
Participants undergoing endoscopic rubber band ligation will be randomly assigned to receive either nitroglycerin ointment or a placebo ointment applied locally after the procedure. Both participants and investigators will be blinded to the treatment assignment. All participants will receive the same standard perioperative care, and rescue pain medication will be provided when necessary.
The primary goal of the study is to compare the proportion of patients who require rescue pain medication within 72 hours after the procedure between the two groups. Secondary outcomes include pain intensity at multiple time points, time to complete pain relief, postoperative complications, treatment-related adverse events, and overall treatment effectiveness at 30 days. The results of this study may help identify a safe and effective option for improving pain control after endoscopic treatment of internal hemorrhoids.
Who can participate
Age range
18 Years – 75 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 to 75 years, male or female
* Diagnosis/indication: Internal hemorrhoids grade I, II, or III scheduled for endoscopic rubber band ligation
* Consent: Able and willing to participate and provide written informed consent
Exclusion Criteria:
* Compliance/assessment: Unable to understand study endpoints or complete study records/forms
* Concomitant medications: Current use of oral nitrates or calcium channel blockers
* Allergy: Known allergy to lactulose oral solution, nitroglycerin ointment, or other study-related medications
* Pregnancy/lactation: Pregnant or breastfeeding women
* Procedure tolerance: Unable to tolerate hemorrhoid band ligation, colonoscopy, or bowel preparation
* Severe comorbidities: Severe cardiac, respiratory, neurologic, or psychiatric disorders
* Legal capacity: Lacking legal capacity for civil conduct or lacking insight/judgment to provide valid consent
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
1
Use of Rescue Analgesic Medication Within 72 Hours After Procedure
Timeframe: 0 to 72 hours after endoscopic rubber band ligation