Nitroglycerin Ointment for Pain Relief After Endoscopic Hemorrhoid Band Ligation

ConditionsInternal Hemorrhoids Postoperative Pain After Endoscopic Rubber 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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.
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.

Treatment groups

68 Participants

are divided into 2 treatment groups

Group A: Nitroglycerin Ointment GroupExperimental treatment 1 intervention

Group B: Placebo Ointment GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

0 to 72 hours after endoscopic rubber band ligation

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ying Zhu

Lead sponsor

Shenzhen Hospital of Southern Medical University

Sponsor institution

Source ClinicalTrials.gov

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