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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhu Ying | Contact | +86-13384662039 | zhuying1@smu.edu.cn |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 13, 2025 | Feb 1, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| 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. |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |