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Oral Nifedipine Versus Placebo for Pain and Healing After Hemorrhoidectomy (NIFEDIPINE-HD)

2026年6月27日 更新者：Haitham Mohammed Jowah、Sana'a University

The Effect of Oral Nifedipine Versus Placebo on Postoperative Pain and Healing Following Hemorrhoidectomy in Adult Patients: A Randomized Controlled Trial in Sana'a, Yemen

The goal of this clinical trial is to evaluate whether oral nifedipine reduces postoperative pain and improves wound healing after hemorrhoidectomy in adult patients aged 18-65 years undergoing elective surgery for grade III or IV hemorrhoids in Sana'a, Yemen.

The main questions it aims to answer are:

  • Does oral nifedipine 20 mg twice daily for 14 days reduce postoperative pain compared with placebo?
  • Does oral nifedipine improve wound healing progression and shorten time to complete healing compared with placebo?

Researchers will compare the nifedipine group to the placebo group to see if there is a significant reduction in pain scores, faster wound healing, lower analgesic consumption, and fewer complications.

Participants will:

  • Take either oral nifedipine 20 mg or an identical-looking placebo capsule twice daily for 14 consecutive days, starting 6 hours after surgery.
  • Report pain intensity using a standard 0-10 Visual Analogue Scale at multiple time points during the first 28 days.
  • Attend follow-up visits on postoperative days 7, 14, and 28 for wound healing assessment and safety monitoring.
  • Use rescue analgesia (paracetamol and/or diclofenac) as needed for breakthrough pain.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Hemorrhoidal disease affects approximately 4.4% of the global population and is one of the most common anorectal conditions. Post-hemorrhoidectomy pain remains the most significant complaint and barrier to recovery, often exceeding patient expectations and delaying return to daily activities. The pathophysiology involves tissue trauma, inflammation, and internal anal sphincter spasm, which creates a cycle of pain and impaired healing. Calcium channel blockers such as nifedipine reduce smooth muscle tone and improve local microcirculation, suggesting benefit in this context. While topical calcium channel blockers have been studied, oral nifedipine offers advantages in compliance, predictable systemic delivery, and suitability for resource-limited settings such as Yemen. This trial addresses a specific gap in evidence for oral nifedipine after hemorrhoidectomy.

研究类型

介入性

注册 (估计的)

100

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Dr. Kholood Ahmed AL-Subari, M.B.B.Ch
  • 电话号码：+967772729669
  • 邮箱：drkholooda@gmail.com

学习地点

  • 也门
      • Sanaa、也门
        • Al-Jumhouri Teaching Hospital
        • 接触：
        • 首席研究员：
          • Dr. Kholood Ahmed AL-Subari, M.B.B.Ch
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Adult patients aged 18-65 years
  • Scheduled for elective hemorrhoidectomy for grade III or IV hemorrhoids
  • Ability to provide written informed consent
  • Ability to understand and complete study questionnaires
  • Willingness to comply with the study protocol and follow-up visits

Exclusion Criteria:

  • Known hypersensitivity to nifedipine
  • Severe cardiovascular disease (unstable angina, recent myocardial infarction, severe heart failure)
  • Hypotension (systolic blood pressure < 90 mmHg)
  • Severe hepatic or renal impairment
  • Pregnancy or breastfeeding
  • Current use of calcium channel blockers or nitrates
  • Emergency hemorrhoidectomy
  • Concurrent inflammatory bowel disease
  • History of anorectal surgery within the past 6 months

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Nifedipine 20 mg oral capsules
Oral nifedipine 20 mg capsule twice daily (every 12 hours) for 14 consecutive days. First dose administered 6 hours after surgery.
药品：Nifedipine 20 Mg
Nifedipine 20 mg immediate-release oral capsule, twice daily for 14 days. First dose 6 hours after surgery. L-type calcium channel blocker causing internal anal sphincter smooth-muscle relaxation, reduced resting pressure, improved local blood flow, and potential anti-inflammatory/analgesic effects.
安慰剂比较：Placebo oral capsules
Identical-appearing placebo capsule (same color, size, taste, and packaging) twice daily for 14 days, starting 6 hours after surgery.
药品：Placebo
Inert placebo capsule matched to nifedipine in color, size, taste, and packaging. Administered twice daily for 14 days, starting 6 hours after surgery.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Visual Analogue Scale (VAS) Pain Score
大体时间：Day 1, Day 2, Day 3, Day 7, Day 14, Day 28
Pain intensity measured on a 0-10 Visual Analogue Scale. Higher scores indicate worse pain. Assessed at rest and with defecation.
Day 1, Day 2, Day 3, Day 7, Day 14, Day 28
Time to Complete Wound Healing
大体时间：Up to Day 28 (censored if not healed by Day 28)
Number of days from surgery until complete epithelialization of all surgical wounds confirmed by clinical examination.
Up to Day 28 (censored if not healed by Day 28)
Redness, Edema, Ecchymosis, Discharge, Approximation (REEDA) Score
大体时间：Day 7, Day 14, Day 28
Redness, Edema, Ecchymosis, Discharge, Approximation (REEDA) score. Range 0-15; lower scores indicate better healing.
Day 7, Day 14, Day 28

次要结果测量

结果测量
措施说明
大体时间
Rescue Analgesic Consumption
大体时间：Day 0 through Day 14
Total number of paracetamol and diclofenac doses consumed during the 14-day study period.
Day 0 through Day 14
Postoperative Complications
大体时间：Day 7, Day 14, Day 28
Incidence of bleeding, infection, urinary retention, and anal stenosis. Binary (yes/no) for each.
Day 7, Day 14, Day 28
Return to Normal Daily Activities
大体时间：Day 28
Number of days until patient reports return to normal daily activities (self-reported).
Day 28
Return to Work
大体时间：Day 28
Number of days until return to employment or usual occupational duties (self-reported).
Day 28
Patient Satisfaction
大体时间：Day 28
Overall satisfaction with pain management and recovery, measured on a Likert scale or binary satisfied/dissatisfied.
Day 28
Adverse Events - General
大体时间：Throughout 14-day treatment and Day 28
Incidence of any serious or non-serious adverse event, including allergic reactions, gastrointestinal symptoms.
Throughout 14-day treatment and Day 28
Adverse Events - Cardiovascular
大体时间：Throughout 14-day treatment and Day 28
Incidence of hypotension (systolic blood pressure [SBP] < 90 mmHg), dizziness, flushing, headache, tachycardia.
Throughout 14-day treatment and Day 28

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Sana'a University

调查人员

  • 研究主任：Dr. Yasser Abdurabo Obadiel, Associate Professor、Faculty of Medicine and Health Sciences, Sana'a University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2026年12月30日

研究完成 (估计的)

2026年12月30日

研究注册日期

首次提交

2026年6月15日

首先提交符合 QC 标准的

2026年6月15日

首次发布 (实际的)

2026年6月22日

研究记录更新

最后更新发布 (实际的)

2026年7月1日

上次提交的符合 QC 标准的更新

2026年6月27日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • NIFEDIPINE-HD-2026-SANA

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

The study team does not plan to share individual participant data with other researchers. This is a single-center thesis study with limited data management infrastructure, and the dataset contains identifiable clinical information that cannot be sufficiently de-identified for broad sharing under local ethical guidelines.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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