Health Trials

Oral Nifedipine Versus Placebo for Pain and Healing After Hemorrhoidectomy

ConditionsHemorrhoidsPostoperative PainWound HealingAnalgesia
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSana'a University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Nifedipine 20 mg oral capsulesExperimental treatment 1 intervention
Group B: Placebo oral capsulesPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 1, Day 2, Day 3, Day 7, Day 14, Day 28
2

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

Redness, Edema, Ecchymosis, Discharge, Approximation (REEDA) score. Range 0-15; lower scores indicate better healing.

Time frame
Day 7, Day 14, Day 28
3

Time to Complete Wound Healing

Number of days from surgery until complete epithelialization of all surgical wounds confirmed by clinical examination.

Time frame
Up to Day 28 (censored if not healed by Day 28)

Secondary outcomes

1

Rescue Analgesic Consumption

Total number of paracetamol and diclofenac doses consumed during the 14-day study period.

Time frame
Day 0 through Day 14
2

Postoperative Complications

Incidence of bleeding, infection, urinary retention, and anal stenosis. Binary (yes/no) for each.

Time frame
Day 7, Day 14, Day 28
3

Return to Normal Daily Activities

Number of days until patient reports return to normal daily activities (self-reported).

Time frame
Day 28
4

Return to Work

Number of days until return to employment or usual occupational duties (self-reported).

Time frame
Day 28

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sana'a University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: