- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04276298
Topical Analgesia Post-Haemorrhoidectomy
A Prospective, Multicentre, Double-Blinded Randomised Controlled Trial Comparing Topical Metronidazole, Diltiazem and Lidocaine on Post-Operative Pain Following Excisional Haemorrhoidectomy
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Auckland, New Zealand, 1041
- Counties Manukau District Health Board
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Metronidazole
Group A receiving 10% metronidazole cream
|
10% metronidazole applied rectally
|
Active Comparator: Metronidazole + Diltiazem
Metronidazole 10% + Diltiazem 2%
|
Combination Metronidazole and Diltiazem applied rectally
|
Active Comparator: Metronidazole + Lignocaine
Metronidazole 10% + Lignocaine 4%
|
Combination metronidazole and lignocaine applied rectally
|
Active Comparator: Metronidazole + Diltiazem + Lignocaine
Metronidazole 10% + Diltiazem 2% + Lignocaine 4%
|
Combination of all active agents tested applied rectally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain scores
Time Frame: 7 days
|
Measured by visual analog scale, 1-10cm, continuous, the higher the score, the worse the pain
|
7 days
|
Amount of analgesic use
Time Frame: 7 days
|
Morphine equivalent amount
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Return to work
Time Frame: 14 days
|
Day post-operation when the patient returns to work
|
14 days
|
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.
|
7 days
|
Complications
Time Frame: 30 days
|
Rates of Bleeding
|
30 days
|
Re-admission
Time Frame: 30 days
|
Rates of Re-admission to hospital,
|
30 days
|
Repeat Prescription
Time Frame: 30 days
|
Rates of Repeat Prescription Requirement
|
30 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Andrew G Hill, MBChB, MD, EdD, FRACS, FACS, Counties Manukau Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Gastrointestinal Diseases
- Intestinal Diseases
- Rectal Diseases
- Hemorrhoids
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Anti-Infective Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anti-Bacterial Agents
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Calcium-Regulating Hormones and Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Calcium Channel Blockers
- Lidocaine
- Metronidazole
- Diltiazem
Other Study ID Numbers
- RCT Haemorrhoidectomy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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