Nitroglycerin Ointment for Pain Relief After Endoscopic Hemorrhoid Band Ligation

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorYing Zhu

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Nitroglycerin Ointment
  • Placebo Ointment

Treatment groups

68 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Ying Zhu

Lead sponsor

Shenzhen Hospital of Southern Medical University

Sponsor institution