A Randomized, Double-Blind, Placebo-Controlled Study of Nitroglycerin Ointment for Postoperative Pain Relief After Endoscopic Rubber Band Ligation of Internal Hemorrhoids
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 主要终点
- Use of Rescue Analgesic Medication Within 72 Hours After Procedure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Nitroglycerin Ointment Group
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.
干预措施: Nitroglycerin Ointment (Drug)
Placebo Ointment Group
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.
干预措施: Placebo Ointment (Drug)
结局指标
主要结局
Use of Rescue Analgesic Medication Within 72 Hours After Procedure
时间窗: 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.
次要结局
未报告次要终点
研究者
Ying Zhu
Principal Investigator, Department of Internal Medicine
Shenzhen Hospital of Southern Medical University