Clinical Trial

Oral Nifedipine Versus Placebo for Pain and Healing After Hemorrhoidectomy

Study acronym: NIFEDIPINE-HD
Not Yet Recruiting Phase 4
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Summary
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.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-07-02
Trial Details
NCT Number NCT07659665
Lead Sponsor Sana'a University
Conditions Hemorrhoids, Postoperative Pain, Wound Healing, Analgesia
Enrollment 100 participants
Start Date 2026-08-01
Primary Completion 2026-12-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-01