NCT07391501

Nitroglycerin Ointment for Pain Relief After Endoscopic Hemorrhoid Band Ligation

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Ying Zhu · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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 protocol when clinically indicated.

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-11-30
• Completion: 2028-11-30
• First posted: 2026-02-05
• Last updated: 2026-02-05