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NCT Number: NCT07659665

Oral Nifedipine Versus Placebo for Pain and Healing After Hemorrhoidectomy

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.

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Key information

Conditions

Hemorrhoids Agnosia Analgesia Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Postoperative Pain Rectal Diseases Signs and Symptoms Vascular Diseases Wound Healing

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Al-Jumhouri Teaching Hospital

Sanaa, Yemen

Location contact

Dr. Kholood Ahmed AL-Subari, M.B.B.Ch

CONTACT

[email protected]

+967772729669

Dr. Kholood Ahmed AL-Subari, M.B.B.Ch

PRINCIPAL_INVESTIGATOR

Dr. Yasser Abdurabo Obadiel, Associate Professor

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Visual Analogue Scale (VAS) Pain Score

    Time frame: Day 1, Day 2, Day 3, Day 7, Day 14, Day 28

    Pain intensity measured on a 0-10 Visual Analogue Scale. Higher scores indicate worse pain. Assessed at rest and with defecation.

  2. Redness, Edema, Ecchymosis, Discharge, Approximation (REEDA) Score

    Time frame: Day 7, Day 14, Day 28

    Redness, Edema, Ecchymosis, Discharge, Approximation (REEDA) score. Range 0-15; lower scores indicate better healing.

  3. Time to Complete Wound Healing

    Time frame: Up to Day 28 (censored if not healed by Day 28)

    Number of days from surgery until complete epithelialization of all surgical wounds confirmed by clinical examination.

Secondary outcomes

  1. Rescue Analgesic Consumption

    Time frame: Day 0 through Day 14

    Total number of paracetamol and diclofenac doses consumed during the 14-day study period.

  2. Postoperative Complications

    Time frame: Day 7, Day 14, Day 28

    Incidence of bleeding, infection, urinary retention, and anal stenosis. Binary (yes/no) for each.

  3. Return to Normal Daily Activities

    Time frame: Day 28

    Number of days until patient reports return to normal daily activities (self-reported).

  4. Return to Work

    Time frame: Day 28

    Number of days until return to employment or usual occupational duties (self-reported).

  5. Patient Satisfaction

    Time frame: Day 28

    Overall satisfaction with pain management and recovery, measured on a Likert scale or binary satisfied/dissatisfied.

  6. Adverse Events - Cardiovascular

    Time frame: Throughout 14-day treatment and Day 28

    Incidence of hypotension (systolic blood pressure [SBP] < 90 mmHg), dizziness, flushing, headache, tachycardia.

  7. Adverse Events - General

    Time frame: Throughout 14-day treatment and Day 28

    Incidence of any serious or non-serious adverse event, including allergic reactions, gastrointestinal symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Kholood Ahmed AL-Subari, M.B.B.Ch

CONTACT

[email protected]

+967772729669

Sponsors and collaborators

Lead sponsor

Sana'a University

Other

Registry information

Official study title

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

Acronym: NIFEDIPINE-HD

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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