Oral Nifedipine vs Placebo for Pain and Healing After Hemorrhoidectomy (NIFEDIPINE-HD)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain; Analgesia; Hemorrhoids; Wound Healing
• Intervention / Treatment: Drug: Nifedipine 20 Mg; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Dr. Kholood Ahmed AL-Subari, M.B.B.Ch; Phone Number: +967772729669; Email: drkholooda@gmail.com

Study Locations

• Yemen
  • Sanaa, Yemen
    • Al-Jumhouri Teaching Hospital
    • Contact: Dr. Kholood Ahmed AL-Subari, M.B.B.Ch; Phone Number: +967772729669; Email: drkholooda@gmail.com
    • Contact: Dr. Yasser Abdurabo Obadiel, Asssociate Professor; Email: Yasser.Obadiel@su.edu.ye
    • Principal Investigator: Dr. Kholood Ahmed AL-Subari, M.B.B.Ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS) Pain Score	Pain intensity measured on a 0-10 Visual Analogue Scale. Higher scores indicate worse pain. Assessed at rest and with defecation.	Day 1, Day 2, Day 3, Day 7, Day 14, Day 28
REEDA Score (Wound Healing)	Redness, Edema, Ecchymosis, Discharge, Approximation score. Range 0-15; lower scores indicate better healing.	Day 7, Day 14, Day 28
Time to Complete Wound Healing	Number of days from surgery until complete epithelialization of all surgical wounds confirmed by clinical examination.	Up to Day 28 (censored if not healed by Day 28)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rescue Analgesic Consumption	Total number of paracetamol and diclofenac doses consumed during the 14-day study period.	Day 0 through Day 14
Postoperative Complications	Incidence of bleeding, infection, urinary retention, and anal stenosis. Binary (yes/no) for each.	Day 7, Day 14, Day 28
Return to Normal Daily Activities	Number of days until patient reports return to normal daily activities (self-reported).	Day 28
Return to Work	Number of days until return to employment or usual occupational duties (self-reported).	Day 28
Patient Satisfaction	Overall satisfaction with pain management and recovery, measured on a Likert scale or binary satisfied/dissatisfied.	Day 28
Adverse Events - Cardiovascular	Incidence of hypotension (SBP < 90 mmHg), dizziness, flushing, headache, tachycardia.	Throughout 14-day treatment and Day 28
Adverse Events - General	Incidence of any serious or non-serious adverse event, including allergic reactions, gastrointestinal symptoms.	Throughout 14-day treatment and Day 28

Collaborators and Investigators

• Sponsor: Sana'a University
• Investigators: Study Director: Dr. Yasser Abdurabo Obadiel, Asssociate Professor, Faculty of Medicine and Health Sciences, Sana'a University

Publications and helpful links

General Publications

• Jin J, Unasa H, Bahl P, Mauiliu-Wallis M, Svirskis D, Hill A. Can Targeting Sphincter Spasm Reduce Post-Haemorrhoidectomy Pain? A Systematic Review and Meta-Analysis. World J Surg. 2023 Feb;47(2):520-533. doi: 10.1007/s00268-022-06807-3. Epub 2022 Nov 10.
• Golfam F, Golfam P, Golfam B, Pahlevani P. Comparison of topical nifedipine with oral nifedipine for treatment of anal fissure: a randomized controlled trial. Iran Red Crescent Med J. 2014 Aug;16(8):e13592. doi: 10.5812/ircmj.13592. Epub 2014 Aug 5.
• Perrotti P, Dominici P, Grossi E, Cerutti R, Antropoli C. Topical nifedipine with lidocaine ointment versus active control for pain after hemorrhoidectomy: results of a multicentre, prospective, randomized, double-blind study. Can J Surg. 2010 Feb;53(1):17-24.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: June 15, 2026
• First Submitted That Met QC Criteria: June 15, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Pain management; Wound healing; Placebo; Nifedipine; Visual Analogue Scale; Hemorrhoidectomy; Calcium channel blocker; Yemen; Anal sphincter spasm; Post-hemorrhoidectomy pain; Internal anal sphincter; REEDA score
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Neurobehavioral Manifestations; Rectal Diseases; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Agnosia; Hemorrhoids; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dihydropyridines; Nifedipine
• Other Study ID Numbers: NIFEDIPINE-HD-2026-SANA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study team does not plan to share individual participant data with other researchers. This is a single-center thesis study with limited data management infrastructure, and the dataset contains identifiable clinical information that cannot be sufficiently de-identified for broad sharing under local ethical guidelines.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No