Nitroglycerin Ointment for Pain Relief After Endoscopic Hemorrhoid Band Ligation

NCT07391501 | Not Yet Recruiting Phase 4

• 1 other identifier: NYSZYYEC2026K010R001
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Internal Hemorrhoids; Postoperative Pain After Endoscopic Rubber Band Ligation

Keywords

Internal Hemorrhoids; Endoscopic Rubber Band Ligation; Postoperative Pain; Nitroglycerin Ointment

Outcome Measures

Primary Outcomes (1)

• Use of Rescue Analgesic Medication Within 72 Hours After Procedure

  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

Study Arms (2)

Nitroglycerin Ointment Group

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.

Drug: Nitroglycerin Ointment

Placebo Ointment Group

PLACEBO COMPARATOR

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

Interventions

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.

Nitroglycerin Ointment Group

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.

Placebo Ointment Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ying Zhu: lead

Related Links

• Related Info

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Zhu Ying

CONTACT

+86-13384662039; zhuying1@smu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Department of Internal Medicine

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 5, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share