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

Inclusion Criteria1

Patients over the age of 18 who are planned for 3-column haemorrhoidectomy, by a closed technique, will be recruited by surgeons during either their initial consultation for haemorrhoidectomy surgery or on the day of planned surgery.

Exclusion Criteria10

Patients who will not be included in the trial will be those who:
i. are under the age of 18
ii. are pregnant or breast feeding
iii. have concurrent non-haemorrhoidal anorectal disease
iv. have a known allergy to nifedipine
v. have comorbidities or take medications that are a contra-indication to nifedipine usage
vi. have impaired renal function where parecoxib is contra-indicated
vii. have a chronic pain condition requiring ongoing regular analgesia
viii. cannot provide informed consent
ix. cannot have a general anaesthetic

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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.