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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04276298




Registration number
NCT04276298
Ethics application status
Date submitted
1/03/2020
Date registered
18/02/2020
Date last updated
10/03/2020

Titles & IDs
Public title
Combination Topical Analgesia Post Haemorrhoidectomy: a Study on Metronidazole, Diltiazem and Lignocaine
Scientific title
A Multi-arm Randomized Clinical Trial on Combination Topical Analgesia Post-haemorrhoidectomy: a Study on Metronidazole, Diltiazem and Lignocaine.
Secondary ID [1] 0 0
APH MDL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemorrhoid Pain 0 0
Hemorrhoids 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Metronidazole cream
Other interventions - Combination Metronidazole and Diltiazem
Other interventions - Combination Metronidazole and Lignocaine
Treatment: Drugs - Combination Metronidazole, Diltiazem and Lignocaine

Active Comparator: Metronidazole - Group A receiving 10% metronidazole cream

Active Comparator: Metronidazole + Diltiazem - Metronidazole 10% + Diltiazem 2%

Active Comparator: Metronidazole + Lignocaine - Metronidazole 10% + Lignocaine 4%

Active Comparator: Metronidazole + Diltiazem + Lignocaine - Metronidazole 10% + Diltiazem 2% + Lignocaine 4%


Treatment: Drugs: Metronidazole cream
10% metronidazole applied rectally

Other interventions: Combination Metronidazole and Diltiazem
Combination Metronidazole and Diltiazem applied rectally

Other interventions: Combination Metronidazole and Lignocaine
Combination metronidazole and lignocaine applied rectally

Treatment: Drugs: Combination Metronidazole, Diltiazem and Lignocaine
Combination of all active agents tested applied rectally

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pain scores - Measured by Visual acuity score, 1-10 the higher the score, the worse the pain
Timepoint [1] 0 0
day 4
Primary outcome [2] 0 0
Amount of analgesic use - Morphine equivalent amount
Timepoint [2] 0 0
day 4
Secondary outcome [1] 0 0
Before and after Microbiome analysis - rectal swab taken to analyse the microbiome of wound size
Timepoint [1] 0 0
day 4

Eligibility
Key inclusion criteria
- Age ≥16

- All patients undergoing excisional haemorrhoidectomy
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Age <16

- Have a simultaneous operation other than excisional haemorrhoidectomy

- History of chronic pain

- Previous allergy/adverse reaction to metronidazole, diltiazem or lignocaine.

- Unable to consent or complete data questionnaires due to cognitive impairment

- Pregnancy, or breastfeeding given Class B status of metronidazole medication

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A multi-arm RCT on the effect of combination metronidazole, diltiazem and lignocaine applied
topically on post haemorrhoidectomy pain.
Trial website
https://clinicaltrials.gov/show/NCT04276298
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
James Jin, MBChB
Address 0 0
Country 0 0
Phone 0 0
6421 0235 1160
Fax 0 0
Email 0 0
james.jin@auckland.ac.nz
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04276298