Oral Nifedipine Versus Placebo for Pain and Healing After Hemorrhoidectomy

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Препарат Placebo
  Inert placebo capsule matched to nifedipine in color, size, taste, and packaging. Administered twice daily for 14 days, starting 6 hours after surgery.

Первичные конечные точки

• Visual Analogue Scale (VAS) Pain Score [Срок оценки: Day 1, Day 2, Day 3, Day 7, Day 14, Day 28]
• Redness, Edema, Ecchymosis, Discharge, Approximation (REEDA) Score [Срок оценки: Day 7, Day 14, Day 28]
• Time to Complete Wound Healing [Срок оценки: Up to Day 28 (censored if not healed by Day 28)]

Вторичные конечные точки (7)

• Rescue Analgesic Consumption [Срок оценки: Day 0 through Day 14]
• Postoperative Complications [Срок оценки: Day 7, Day 14, Day 28]
• Return to Normal Daily Activities [Срок оценки: Day 28]
• Return to Work [Срок оценки: Day 28]
• Patient Satisfaction [Срок оценки: Day 28]
• Adverse Events - Cardiovascular [Срок оценки: Throughout 14-day treatment and Day 28]
• Adverse Events - General [Срок оценки: Throughout 14-day treatment and Day 28]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Yemen · 1 центр

• Al-Jumhouri Teaching Hospital — Sanaa

Публикации

• Golfam F, Golfam P, Golfam B, Pahlevani P. Comparison of topical nifedipine with oral nifedipine for treatment of anal fissure: a randomized controlled trial. Iran Red Crescent Med J. 2014 Aug;16(8):e13592. doi: 10.5812/ircmj.13592. Epub 2014 Aug 5. PMID 25389477
• Jin J, Unasa H, Bahl P, Mauiliu-Wallis M, Svirskis D, Hill A. Can Targeting Sphincter Spasm Reduce Post-Haemorrhoidectomy Pain? A Systematic Review and Meta-Analysis. World J Surg. 2023 Feb;47(2):520-533. doi: 10.1007/s00268-022-06807-3. Epub 2022 Nov 10. PMID 36357803
• Perrotti P, Dominici P, Grossi E, Cerutti R, Antropoli C. Topical nifedipine with lidocaine ointment versus active control for pain after hemorrhoidectomy: results of a multicentre, prospective, randomized, double-blind study. Can J Surg. 2010 Feb;53(1):17-24. PMID 20100408

Идентификаторы

NCT: NCT07659665 · NIFEDIPINE-HD-2026-SANA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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