Nitroglycerin Ointment for Pain Relief After Endoscopic Hemorrhoid Band Ligation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nitroglycerin Ointment, Placebo Ointment.
- Who it may be relevant to
- Registry conditions: Internal Hemorrhoids, Postoperative Pain After Endoscopic Rubber Band Ligation. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized, Double-Blind, Placebo-Controlled Study of Nitroglycerin Ointment for Postoperative Pain Relief After Endoscopic Rubber Band Ligation of Internal Hemorrhoids
Overview
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.
Interventions
- Drug Nitroglycerin Ointment
Nitroglycerin ointment will be applied locally to the intrarectal wound area after endoscopic rubber band ligation for internal hemorrhoids. Treatment will begin immediately after the procedure. Participants will apply approximately 1-1.5 cm of ointment three times daily for a total duration of 2 weeks, in addition to standard perioperative management. Rescue analgesia with oral loxoprofen sodium will be permitted according to the predefined protocol when clinically indicated. - Drug Placebo Ointment
A placebo ointment identical in appearance and packaging to the study drug will be applied locally to the intrarectal wound area after endoscopic rubber band ligation for internal hemorrhoids. Treatment will begin immediately after the procedure. Participants will apply approximately 1-1.5 cm of ointment three times daily for a total duration of 2 weeks, in addition to standard perioperative management. Rescue analgesia with oral loxoprofen sodium will be permitted according to the predefined pr
Primary outcome measures
- Use of Rescue Analgesic Medication Within 72 Hours After Procedure [Time frame: 0 to 72 hours after endoscopic rubber band ligation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07391501 · NYSZYYEC2026K010R001