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Nitroglycerin Ointment for Postoperative Pain Relief After Endoscopic Rubber Band Ligation of Internal Hemorrhoids

Study Aim

This study aims to evaluate the effectiveness of Nitroglycerin Ointment in reducing postoperative pain after Endoscopic Rubber Band Ligation of Internal Hemorrhoids, specifically by observing the need for rescue analgesic medication within 72 hours after the procedure.

What is being tested

Nitroglycerin Ointment

+ Placebo Ointment

Drug

Who is being recruted

Neurologic Manifestations+4

+ Pain

+ Pain, Postoperative

From 18 to 75 Years

+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 4

Interventional

Study Start: February 2026

See protocol details

Summary

Principal SponsorYing Zhu

Study ContactZhu Ying

Last updated: February 6, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2026

Actual date on which the first participant was enrolled.

This study focuses on finding a solution to reduce pain after a common procedure for internal hemorrhoids, known as endoscopic rubber band ligation. The procedure is minimally invasive, but it often leads to anal pain that can hinder daily activities and recovery. The study aims to evaluate the effectiveness of nitroglycerin ointment in easing this pain. The importance of this study lies in its potential to improve patient comfort and speed up recovery after the procedure. In this study, participants who undergo the endoscopic rubber band ligation procedure are randomly assigned to use either nitroglycerin ointment or a placebo ointment. Neither the participants nor the investigators know who is using which ointment. All participants receive the same standard care during and after the procedure, and additional pain medication is provided when necessary. The main goal is to compare the number of patients who need extra pain medication within 72 hours after the procedure between the two groups. Other outcomes include measuring pain intensity at different times, the time it takes for complete pain relief, any complications after the procedure, side effects from the treatment, and overall treatment effectiveness at 30 days.

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

NCT07391501

Principal SponsorYing Zhu

Study ContactZhu Ying

Last updated: February 6, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

68 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsPainPain, PostoperativePathologic ProcessesPostoperative ComplicationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Criteria

3 inclusion criteria required to participate

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

Age: 18 to 75 years, male or female

7 exclusion criteria prevent from participating

Allergy: Known allergy to lactulose oral solution, nitroglycerin ointment, or other study-related medications

Pregnancy/lactation: Pregnant or breastfeeding women

Compliance/assessment: Unable to understand study endpoints or complete study records/forms

Legal capacity: Lacking legal capacity for civil conduct or lacking insight/judgment to provide valid consent

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Participants in this arm will receive standard perioperative management following endoscopic rubber band ligation for internal hemorrhoids, plus topical nitroglycerin ointment. The ointment will be applied to the intrarectal wound area starting after the procedure, three times daily, with approximately 1-1.5 cm of ointment per application, for a total duration of 2 weeks. Rescue analgesia with oral loxoprofen sodium will be permitted according to the predefined protocol when clinically indicated.

Group II

Placebo

Participants in this arm will receive standard perioperative management following endoscopic rubber band ligation for internal hemorrhoids, plus a placebo ointment identical in appearance to the study drug. The placebo ointment will be applied to the intrarectal wound area starting after the procedure, three times daily, with approximately 1-1.5 cm of ointment per application, for a total duration of 2 weeks. Rescue analgesia with oral loxoprofen sodium will be permitted according to the predefined protocol when clinically indicated.

Study Objectives

Primary Objectives

Study Centers

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