Nitroglycerin Ointment for Pain Relief After Endoscopic Hemorrhoid Band Ligation

February 1, 2026 updated by: Ying Zhu

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nitroglycerin Ointment Group
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.
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.
Placebo Comparator: Placebo Ointment Group
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.
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 protocol when clinically indicated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 to 72 hours after endoscopic rubber band ligation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ying Zhu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

November 30, 2028

Study Registration Dates

First Submitted

January 25, 2026

First Submitted That Met QC Criteria

February 1, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 1, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NYSZYYEC2026K010R001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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