Internal Hemorrhoids, Postoperative Pain After Endoscopic Rubber Band Ligation
Conditions
Keywords
Internal Hemorrhoids, Endoscopic Rubber Band Ligation, Postoperative Pain, Nitroglycerin Ointment
Brief 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.
Interventions
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.
DRUGPlacebo 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.
Sponsors
Ying Zhu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Use of Rescue Analgesic Medication Within 72 Hours After Procedure | 0 to 72 hours after endoscopic rubber band ligation | 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. |
Contacts
CONTACTZhu Ying
Outcome results
None listed