Oral Nifedipine Versus Placebo for Pain and Healing After Hemorrhoidectomy

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSana'a University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Nifedipine 20 Mg
  • Placebo

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators