Topical Analgesia Post-Haemorrhoidectomy

  • STATUS
    Recruiting
  • End date
    Sep 1, 2022
  • participants needed
    192
  • sponsor
    University of Auckland, New Zealand
Updated on 26 January 2021
analgesia
metronidazole
combinations
lidocaine
hemorrhoidectomy

Summary

Symptomatic haemorrhoids, or piles, have significant effects on quality of life. The treatment for advanced disease is surgical excision (haemorrhoidectomy) which is extremely effective. However, pain following haemorrhoidectomy is known by all to be a miserable experience and current treatment is not very effective. We have formulated a new cream treatment which targets three theorised mechanisms of pain after haemorrhoidectomy. We will test the effectiveness of the treatments with a multi-centred randomised controlled factorial trial with four parallel double-blinded arms containing different combinations of the active agents. The outcomes include pain scores, amount of analgesia required and time to return to work. The results of our study could provide evidence of an effective treatment for post haemorrhoidectomy pain. The treatment may provide considerable benefit to patients undergoing this surgical procedure.

Description

Study Design: This will be a patient-and-investigator blinded factorial randomised trial with four parallel groups. Participants in all four groups will be instructed to apply cream 3 times a day for 7 days after surgery. A standard analgesia prescription will be provided with laxatives as per routine care. Patients will be provided a questionnaire to complete and return on day 14.

Random Sequence Generation: Computer generated sequence allocating patients to a 1:1:1:1 ratio using permuted block randomisation in blocks of 12.

Allocation Concealment: This randomisation code will be seeded to the pharmacist to who will package and label the cream according to a code. The creams will be indistinguishable to which active ingredient they contain.

Assignment of intervention: Patients will be assigned in order according to the numbering of the cream tubes by the blinded investigator.

Data recording: Data will be recorded on Redcap database.

Details
Condition Rectal disorder, Hemorrhoids, Vascular Diseases, Rectal Disorders, Hemorrhoid Pain
Treatment Metronidazole cream, Metronidazole and Diltiazem cream, Metronidazole and Lidocaine cream, Metronidazole, Diltiazem and Lidocaine cream
Clinical Study IdentifierNCT04276298
SponsorUniversity of Auckland, New Zealand
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 16
All patients undergoing excisional haemorrhoidectomy

Exclusion Criteria

Age <16
history of chronic pain
drug allergy or idiosyncracies to any actives or excipients in
cream
breastfeeding
any medical history which is a contraindication to any of metronidazole, lidocaine, or diltiazem including including
sick sinus syndrome
atrioventricular block
hypotension
heart failure and bradycardia
concomitant medications which are contraindicated to metronidazole, lidocaine or diltiazem
patients already taking diltiazem
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