RecruitingPhase 3Phase 4ACTRN12623000514606

Topical nifedipine for post haemorrhoidectomy pain relief

Topical nifedipine for post haemorrhoidectomy pain relief: a multi centre randomised, prospective, double-blind placebo trial

Sponsor

Dr Christopher Steen

Enrollment

60 participants

Start Date

Oct 16, 2024

Study Type

Interventional

Conditions

Haemorrhoidectomy Pain

Summary

Haemorrhoidectomy (surgical removal of haemorrhoid) is a common surgical procedure carried out by general and colorectal surgeons worldwide. Pain following haemorrhoidectomy is universal and problematic, causing absenteeism from work and school as well as a hospital readmission for pain relief. This is thought to be related to spasm of the anal sphincter muscles or creation of an anal fissure. Topical medications to aid in pain relief are well studied and accepted due to their ready availability and low side effects. Calcium channel blockers (CCB), such as diltiazem and nifedipine, are available in topical preparation, and are thought to aid in pain relief by decreasing muscle spasm. Whilst there are some studies accessing the role of CCB in post haemorrhoidectomy pain relief, most are focussed on diltiazem. Interestingly, nifedipine has reported better healing rates in anal fissure than diltiazem. This study aims to ascertain the effectiveness of topical nifedipine versus placebo as a post operative adjunct in the hopes of reducing pain experienced and reducing the post-operative short-term disability associated with haemorrhoidectomy.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

Haemorrhoidectomy — the surgical removal of haemorrhoids — is one of the most common procedures performed by surgeons, but it is notorious for causing significant pain afterward. This pain is thought to result from spasm of the anal sphincter muscles and can be severe enough to require hospital readmission. This study is testing whether a topical cream containing nifedipine — a type of blood pressure medication that relaxes smooth muscle — applied around the surgical site after the operation can reduce pain and speed recovery. Participants will be randomly assigned to receive either the nifedipine cream or a placebo cream for the days following surgery, and pain levels will be monitored closely. You may be eligible if you are aged 18–80, are scheduled for a haemorrhoidectomy by a specific closed surgical technique, and have no known allergy to nifedipine. Women who are pregnant or breastfeeding, those with concurrent anorectal conditions, and those who cannot have a general anaesthetic are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

To assess the efficacy of topical (0.5%) nifedipine ointment for reducing post haemorrhoidectomy pain. Participants will be instructed to apply a pea-sized amount of their ointment, using a glove, 1-1.5cm into the anus circumferentially, as well as to the external anus. This will be done twice a day for four weeks. Follow up will consist of post operative questionnaire's to complete.