Nitroglycerin Ointment for Pain Relief After Endoscopic Hemorrhoid Band Ligation

Ying Zhu

Status and phase: Not yet enrolling; Phase 4

Conditions: Internal Hemorrhoids; Postoperative Pain After Endoscopic Rubber Band Ligation

Treatments: Drug: Nitroglycerin Ointment; Drug: Placebo Ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT07391501

NYSZYYEC2026K010R001

Details and patient eligibility

About

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.

Enrollment: 68 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups, including a placebo group

Nitroglycerin Ointment Group

Experimental group

Description:

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.

Treatment:

Drug: Nitroglycerin Ointment

Placebo Ointment Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo Ointment