Topical Analgesia Post-Haemorrhoidectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-02-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hemorrhoid Pain Hemorrhoids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Parallel with 1:1:1:1 Allocation.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Double blinded trial, both participant and investigator are blinded.

Study Groups

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Metronidazole

Group A receiving 10% metronidazole cream

Group Type ACTIVE_COMPARATOR

Metronidazole cream

Intervention Type DRUG

10% metronidazole applied rectally

Metronidazole + Diltiazem

Metronidazole 10% + Diltiazem 2%

Group Type ACTIVE_COMPARATOR

Metronidazole and Diltiazem cream

Intervention Type DRUG

Combination Metronidazole and Diltiazem applied rectally

Metronidazole + Lignocaine

Metronidazole 10% + Lignocaine 4%

Group Type ACTIVE_COMPARATOR

Metronidazole and Lidocaine cream

Intervention Type DRUG

Combination metronidazole and lignocaine applied rectally

Metronidazole + Diltiazem + Lignocaine

Metronidazole 10% + Diltiazem 2% + Lignocaine 4%

Group Type ACTIVE_COMPARATOR

Metronidazole, Diltiazem and Lidocaine cream

Intervention Type DRUG

Combination of all active agents tested applied rectally

Interventions

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Metronidazole cream

10% metronidazole applied rectally

Intervention Type DRUG

Metronidazole and Diltiazem cream

Combination Metronidazole and Diltiazem applied rectally

Intervention Type DRUG

Metronidazole and Lidocaine cream

Combination metronidazole and lignocaine applied rectally

Intervention Type DRUG

Metronidazole, Diltiazem and Lidocaine cream

Combination of all active agents tested applied rectally

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes