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
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Redness, Edema, Ecchymosis, Discharge, Approximation (REEDA) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
In addition to the four checked roles, the independent statistician performing data analysis and the independent pharmacist preparing study capsules are also masked to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo oral capsules
Identical-appearing placebo capsule (same color, size, taste, and packaging) twice daily for 14 days, starting 6 hours after surgery.
干预措施: Placebo (Drug)
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.
干预措施: Nifedipine 20 Mg (Drug)
结局指标
主要结局
Redness, Edema, Ecchymosis, Discharge, Approximation (REEDA) Score
时间窗: Day 7, Day 14, Day 28
Redness, Edema, Ecchymosis, Discharge, Approximation (REEDA) score. Range 0-15; lower scores indicate better healing.
次要结局
- Adverse Events - Cardiovascular(Throughout 14-day treatment and Day 28)
研究者
Haitham Mohammed Jowah
Lecturer
Sana'a University