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NCT Number: NCT04276298

Topical Analgesia Post-Haemorrhoidectomy

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.

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Key information

Conditions

Hemorrhoid Pain Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Hemorrhoids Intestinal Diseases Rectal Diseases Vascular Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Counties Manukau District Health Board

Auckland, 1041, New Zealand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metronidazole cream

Drug

10% metronidazole applied rectally

Metronidazole and Diltiazem cream

Drug

Combination Metronidazole and Diltiazem applied rectally

Metronidazole and Lidocaine cream

Drug

Combination metronidazole and lignocaine applied rectally

Metronidazole, Diltiazem and Lidocaine cream

Drug

Combination of all active agents tested applied rectally

Primary outcomes

  1. Pain scores

    Time frame: 7 days

    Measured by visual analog scale, 1-10cm, continuous, the higher the score, the worse the pain

  2. Amount of analgesic use

    Time frame: 7 days

    Morphine equivalent amount

Secondary outcomes

  1. Return to work

    Time frame: 14 days

    Day post-operation when the patient returns to work

  2. Pain on bowel motion: Visual Analog Scale

    Time frame: 7 days

    Measured by Visual Analog Scale, continuous 1-10cm, the higher the score, the worse the pain.

  3. Complications

    Time frame: 30 days

    Rates of Bleeding

  4. Re-admission

    Time frame: 30 days

    Rates of Re-admission to hospital,

  5. Repeat Prescription

    Time frame: 30 days

    Rates of Repeat Prescription Requirement

Sponsors and collaborators

Lead sponsor

University of Auckland, New Zealand

Other

Registry information

Official study title

A Prospective, Multicentre, Double-Blinded Randomised Controlled Trial Comparing Topical Metronidazole, Diltiazem and Lidocaine on Post-Operative Pain Following Excisional Haemorrhoidectomy

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 19, 2020
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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