Oral Nifedipine Versus Placebo for Pain and Healing After Hemorrhoidectomy

Sponsor
Sana'a University
Study ID
NCT07659665
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Nifedipine 20 Mg — DRUG
    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.
  • Placebo — DRUG
    Inert placebo capsule matched to nifedipine in color, size, taste, and packaging. Administered twice daily for 14 days, starting 6 hours after surgery.

Study Details

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.

Key Dates

First listed
Jun 22, 2026
Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Placebo Comparator: Placebo oral capsules
    Identical-appearing placebo capsule (same color, size, taste, and packaging) twice daily for 14 days, starting 6 hours after surgery.

Primary Outcome Measure

Visual Analogue Scale (VAS) Pain Score [ Time Frame: Day 1, Day 2, Day 3, Day 7, Day 14, Day 28 ]

Central Contacts

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