HemorrhoidsPhase 4NIFEDIPINE-HDNCT07659665
Oral Nifedipine Versus Placebo for Pain and Healing After Hemorrhoidectomy
A Phase 4 study testing Nifedipine 20 Mg in people with Hemorrhoids and Postoperative Pain, run by Sana'a University at 1 site in Yemen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hemorrhoids, Postoperative Pain, Wound Healing
- What is being tested?
- Nifedipine 20 Mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteYemen
- Study dates
- 1 Aug 2026to 30 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Emergency hemorrhoidectomy
- Concurrent inflammatory bowel disease
- History of anorectal surgery within the past 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yemen1 site
Al-Jumhouri Teaching Hospital
Sanaa
Dr. Kholood Ahmed AL-Subari, M.B.B.Ch, +967772729669, drkholooda@gmail.com
Dr. Yasser Abdurabo Obadiel, Associate Professor, Yasser.Obadiel@su.edu.ye
About this study
Official 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
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:
Read more
- 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.
Read the 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.
- Conditions
- Hemorrhoids, Postoperative Pain, Wound Healing, Analgesia
- Being tested
- Nifedipine 20 Mg, Placebo
- 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
- Medical subject headings
- Hemorrhoids, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifedipine 20 MgDrug
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.
PlaceboDrug
Inert placebo capsule matched to nifedipine in color, size, taste, and packaging. Administered twice daily for 14 days, starting 6 hours after surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to Day 28 (censored if not healed by Day 28)
Secondary outcomes (7)
Rescue Analgesic Consumption
Total number of paracetamol and diclofenac doses consumed during the 14-day study period.
Measured: Day 0 through Day 14
Postoperative Complications
Incidence of bleeding, infection, urinary retention, and anal stenosis. Binary (yes/no) for each.
Measured: Day 7, Day 14, Day 28
Return to Normal Daily Activities
Number of days until patient reports return to normal daily activities (self-reported).
Measured: Day 28
Return to Work
Number of days until return to employment or usual occupational duties (self-reported).
Measured: Day 28
Patient Satisfaction
Overall satisfaction with pain management and recovery, measured on a Likert scale or binary satisfied/dissatisfied.
Measured: Day 28
Adverse Events - Cardiovascular
Incidence of hypotension (systolic blood pressure [SBP] < 90 mmHg), dizziness, flushing, headache, tachycardia.
Measured: Throughout 14-day treatment and Day 28
Adverse Events - General
Incidence of any serious or non-serious adverse event, including allergic reactions, gastrointestinal symptoms.
Measured: Throughout 14-day treatment and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sana'a University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haitham Mohammed Jowah, Sana'a University
- Investigators
- Dr. Yasser Abdurabo Obadiel, Associate Professor, Study director, Faculty of Medicine and Health Sciences, Sana'a University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659665
- Sponsor's protocol ID
- NIFEDIPINE-HD-2026-SANA
- Acronym
- NIFEDIPINE-HD
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 25389477Jin 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.
PubMed 36357803Perrotti 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.
PubMed 20100408
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07659665
- Acronym / sponsor ID
- NIFEDIPINE-HD / NIFEDIPINE-HD-2026-SANA
- Conditions
- Hemorrhoids, Postoperative Pain, Wound Healing, Analgesia
- Keywords
- Hemorrhoidectomy, Post-hemorrhoidectomy pain, Internal anal sphincter, Anal sphincter spasm, Nifedipine, Calcium channel blocker, Randomized controlled trial, Yemen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sana'a UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nifedipine 20 mg oral capsules | Experimental | Drug: Nifedipine 20 MgOral nifedipine 20 mg capsule twice daily (every 12 hours) for 14 consecutive days. First dose administered 6 hours after surgery. |
| Placebo oral capsules | Placebo comparator | Drug: PlaceboIdentical-appearing placebo capsule (same color, size, taste, and packaging) twice daily for 14 days, starting 6 hours after surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nifedipine 20 MgNifedipine 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 | Nifedipine 20 mg oral capsules |
| PlaceboInert placebo capsule matched to nifedipine in color, size, taste, and packaging. Administered twice daily for 14 days, starting 6 hours after surgery. | Drug | Placebo oral capsules |
Primary outcome
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.
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.
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.
7 secondary outcomes
Rescue Analgesic Consumption
Time frame: Day 0 through Day 14
Postoperative Complications
Time frame: Day 7, Day 14, Day 28
Return to Normal Daily Activities
Time frame: Day 28
Return to Work
Time frame: Day 28
Patient Satisfaction
Time frame: Day 28
Adverse Events - Cardiovascular
Time frame: Throughout 14-day treatment and Day 28
Adverse Events - General
Time frame: Throughout 14-day treatment and Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Background: PubMed 25389477Golfam 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.
- Background: PubMed 36357803Jin 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.
- Background: PubMed 20100408Perrotti 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Yasser Abdurabo Obadiel, Associate Professor study director
Faculty of Medicine and Health Sciences, Sana'a University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nifedipine 20 Mg in people with Hemorrhoids and Postoperative Pain, run by Sana'a University at 1 site in Yemen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Yemen. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Kholood Ahmed AL-Subari, M.B.B.Ch (+967772729669, drkholooda@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) Pain Score (time frame: Day 1, Day 2, Day 3, Day 7, Day 14, Day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07659665, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.