Oral Nifedipine Versus Placebo for Pain and Healing After Hemorrhoidectomy

NCT07659665 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: NIFEDIPINE-HD-2026-SANA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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; Analgesia; Wound Healing

Keywords

Hemorrhoidectomy; Post-hemorrhoidectomy pain; Internal anal sphincter; Anal sphincter spasm; Nifedipine; Calcium channel blocker; Randomized controlled trial; Yemen; Placebo; Visual Analogue Scale; Pain management; Wound healing; Ecchymosis Discharge Approximation score

Outcome Measures

Primary Outcomes (3)

• 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

• Redness, Edema, Ecchymosis, Discharge, Approximation (REEDA) Score

  Redness, Edema, Ecchymosis, Discharge, Approximation (REEDA) 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 Outcomes (7)

• Rescue Analgesic Consumption

  Day 0 through Day 14

• Postoperative Complications

  Day 7, Day 14, Day 28

• Return to Normal Daily Activities

  Day 28

• Return to Work

  Day 28

• Patient Satisfaction

  Day 28

Study Arms (2)

Nifedipine 20 mg oral capsules

EXPERIMENTAL

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

Placebo oral capsules

PLACEBO COMPARATOR

Identical-appearing placebo capsule (same color, size, taste, and packaging) twice daily for 14 days, starting 6 hours after surgery.

Drug: Placebo

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.

Nifedipine 20 mg oral capsules

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.

Placebo oral capsules

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sana'a University: lead

Study Sites (1)

Al-Jumhouri Teaching Hospital

Sanaa, Yemen

Location

Related Publications (3)

• 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.

  PMID: 25389477 BACKGROUND

• 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.

  PMID: 36357803 BACKGROUND

• 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.

  PMID: 20100408 BACKGROUND

MeSH Terms

Conditions

Hemorrhoids; Pain, Postoperative; Agnosia

Interventions

Nifedipine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dr. Yasser Abdurabo Obadiel, Associate Professor

  Faculty of Medicine and Health Sciences, Sana'a University

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

+967772729669; drkholooda@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In addition to the four checked roles, the independent statistician performing data analysis and the independent pharmacist preparing study capsules are also masked to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Parallel assignment with 1:1 allocation. Participants randomized to either oral nifedipine 20 mg twice daily or identical placebo for 14 days post-hemorrhoidectomy. No crossover. Block randomization (block size 4, variable) with sequentially numbered opaque sealed envelopes (SNOSE) for allocation concealment.

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 22, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

YE (1)