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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
Ethics application status
Date submitted
Date registered
Date last updated

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
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

Study type
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

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

Key inclusion criteria
- Age ≥16

- All patients undergoing excisional haemorrhoidectomy
Minimum age
16 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Phase 2/Phase 3
Type of endpoint(s)
Statistical methods / analysis

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

Funding & Sponsors
Primary sponsor type
University of Auckland, New Zealand

Ethics approval
Ethics application status

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

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
Contact person for scientific queries

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