Analgesia, Hemorrhoids, Postoperative Pain, Wound Healing
Conditions
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
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.
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.
Interventions
DRUGNifedipine 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.
DRUGPlacebo
Inert placebo capsule matched to nifedipine in color, size, taste, and packaging. Administered twice daily for 14 days, starting 6 hours after surgery.
Sponsors
Sana'a University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) Pain Score | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Rescue Analgesic Consumption | Day 0 through Day 14 | Total number of paracetamol and diclofenac doses consumed during the 14-day study period. |
| Postoperative Complications | Day 7, Day 14, Day 28 | Incidence of bleeding, infection, urinary retention, and anal stenosis. Binary (yes/no) for each. |
| Return to Normal Daily Activities | Day 28 | Number of days until patient reports return to normal daily activities (self-reported). |
| Return to Work | Day 28 | Number of days until return to employment or usual occupational duties (self-reported). |
| Patient Satisfaction | Day 28 | Overall satisfaction with pain management and recovery, measured on a Likert scale or binary satisfied/dissatisfied. |
| Adverse Events - Cardiovascular | Throughout 14-day treatment and Day 28 | Incidence of hypotension (systolic blood pressure \[SBP\] \< 90 mmHg), dizziness, flushing, headache, tachycardia. |
| Adverse Events - General | Throughout 14-day treatment and Day 28 | Incidence of any serious or non-serious adverse event, including allergic reactions, gastrointestinal symptoms. |
Countries
Yemen
Contacts
CONTACTDr. Kholood Ahmed AL-Subari, M.B.B.Ch
STUDY_DIRECTORDr. Yasser Abdurabo Obadiel, Associate Professor
Faculty of Medicine and Health Sciences, Sana'a University
Outcome results
None listed