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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04276298
Ethics application status
Date submitted
17/02/2020
Date registered
19/02/2020

Titles & IDs
Public title
Topical Analgesia Post-Haemorrhoidectomy
Scientific title
A Prospective, Multicentre, Double-Blinded Randomised Controlled Trial Comparing Topical Metronidazole, Diltiazem and Lidocaine on Post-Operative Pain Following Excisional Haemorrhoidectomy
Secondary ID [1] 0 0
RCT Haemorrhoidectomy
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
Treatment: Drugs - Metronidazole and Diltiazem cream
Treatment: Drugs - Metronidazole and Lidocaine cream
Treatment: Drugs - Metronidazole, Diltiazem and Lidocaine cream

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

Treatment: Drugs: Metronidazole and Diltiazem cream
Combination Metronidazole and Diltiazem applied rectally

Treatment: Drugs: Metronidazole and Lidocaine cream
Combination metronidazole and lignocaine applied rectally

Treatment: Drugs: Metronidazole, Diltiazem and Lidocaine cream
Combination of all active agents tested applied rectally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pain scores
Timepoint [1] 0 0
7 days
Primary outcome [2] 0 0
Amount of analgesic use
Timepoint [2] 0 0
7 days
Secondary outcome [1] 0 0
Return to work
Timepoint [1] 0 0
14 days
Secondary outcome [2] 0 0
Pain on bowel motion: Visual Analog Scale
Timepoint [2] 0 0
7 days
Secondary outcome [3] 0 0
Complications
Timepoint [3] 0 0
30 days
Secondary outcome [4] 0 0
Re-admission
Timepoint [4] 0 0
30 days
Secondary outcome [5] 0 0
Repeat Prescription
Timepoint [5] 0 0
30 days

Eligibility
Key inclusion criteria
* Age =16
* All patients undergoing excisional haemorrhoidectomy
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

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
Factorial
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2022
Sample size
Target
Accrual to date
Final
192
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew G Hill, MBChB, MD, EdD, FRACS, FACS
Address 0 0
Counties Manukau Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04276298