Nitroglycerin Ointment for Pain Relief After Endoscopic Hemorrhoid Band Ligation

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Internal Hemorrhoids Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain After Endoscopic Rubber Band Ligation Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nitroglycerin Ointment

Drug

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.

Placebo Ointment

Drug

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 protocol when clinically indicated.

Primary outcomes

Use of Rescue Analgesic Medication Within 72 Hours After Procedure

Time frame: 0 to 72 hours after endoscopic rubber band ligation

The primary outcome is the proportion of participants who require rescue analgesic medication within 72 hours after endoscopic rubber band ligation for internal hemorrhoids. Rescue analgesia is defined as the use of oral loxoprofen sodium tablets at least once during the postoperative period from 0 to 72 hours. The timing, dose, frequency, and cumulative amount of rescue analgesic use will be recorded for each participant.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhu Ying

CONTACT

[email protected]

+86-13384662039

Sponsors and collaborators

Lead sponsor

Ying Zhu

Other

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Study of Nitroglycerin Ointment for Postoperative Pain Relief After Endoscopic Rubber Band Ligation of Internal Hemorrhoids

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Feb 5, 2026
Registry last updated: Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting