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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
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.
Inert placebo capsule matched to nifedipine in color, size, taste, and packaging. Administered twice daily for 14 days, starting 6 hours after surgery.
Al-Jumhouri Teaching Hospital
Sanaa, Yemen
Visual Analogue Scale (VAS) Pain Score
Pain intensity measured on a 0-10 Visual Analogue Scale. Higher scores indicate worse pain. Assessed at rest and with defecation.
Time frame: Day 1, Day 2, Day 3, Day 7, Day 14, Day 28
Redness, Edema, Ecchymosis, Discharge, Approximation (REEDA) Score
Redness, Edema, Ecchymosis, Discharge, Approximation (REEDA) score. Range 0-15; lower scores indicate better healing.
Time frame: Day 7, Day 14, Day 28
Time to Complete Wound Healing
Number of days from surgery until complete epithelialization of all surgical wounds confirmed by clinical examination.
Time frame: Up to Day 28 (censored if not healed by Day 28)
Rescue Analgesic Consumption
Total number of paracetamol and diclofenac doses consumed during the 14-day study period.
Time frame: Day 0 through Day 14
Postoperative Complications
Incidence of bleeding, infection, urinary retention, and anal stenosis. Binary (yes/no) for each.
Time frame: Day 7, Day 14, Day 28
Return to Normal Daily Activities
Number of days until patient reports return to normal daily activities (self-reported).
Time frame: Day 28
Return to Work
Number of days until return to employment or usual occupational duties (self-reported).
Time frame: Day 28
Patient Satisfaction
Overall satisfaction with pain management and recovery, measured on a Likert scale or binary satisfied/dissatisfied.
Time frame: Day 28
Adverse Events - Cardiovascular
Incidence of hypotension (systolic blood pressure \[SBP\] \< 90 mmHg), dizziness, flushing, headache, tachycardia.
Time frame: Throughout 14-day treatment and Day 28
Adverse Events - General
Incidence of any serious or non-serious adverse event, including allergic reactions, gastrointestinal symptoms.
Time frame: Throughout 14-day treatment and Day 28
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