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Oral Nifedipine Versus Placebo for Pain and Healing After Hemorrhoidectomy

NCT07659665 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-07-01

No results posted yet for this study

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.

Conditions

  • Hemorrhoids
  • Postoperative Pain
  • Wound Healing
  • Analgesia

Interventions

DRUG

Nifedipine 20 Mg

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.

DRUG

Placebo

Inert placebo capsule matched to nifedipine in color, size, taste, and packaging. Administered twice daily for 14 days, starting 6 hours after surgery.

Sponsors & Collaborators

  • Sana'a University

    lead OTHER

Principal Investigators

  • Dr. Yasser Abdurabo Obadiel, Associate Professor · Faculty of Medicine and Health Sciences, Sana'a University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2026-12-30
Completion
2026-12-30

Countries

  • Yemen

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07659665 on ClinicalTrials.gov