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Combination Topical Analgesia Post Haemorrhoidectomy: a Study on Metronidazole, Diltiazem and Lignocaine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04276298
Recruitment Status : Not yet recruiting
First Posted : February 19, 2020
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
Andrew G Hill, MBChB, MD (Thesis), EdD, FACS, FRACS, University of Auckland, New Zealand

Brief Summary:
A multi-arm RCT on the effect of combination metronidazole, diltiazem and lignocaine applied topically on post haemorrhoidectomy pain.

Condition or disease Intervention/treatment Phase
Hemorrhoid Pain Hemorrhoids Drug: Metronidazole cream Other: Combination Metronidazole and Diltiazem Other: Combination Metronidazole and Lignocaine Drug: Combination Metronidazole, Diltiazem and Lignocaine Phase 2 Phase 3

Detailed Description:
A multi arm RCT will be randomized 1:1:1:1 Mutli-centre recruitment will take place across the Auckland Region. We will recruit 52 patients across each arm. Treatment will be either metronidazole alone, or combination metronidazole and diltiazem or combination metronidazole and lignocaine or combination metronidazole, diltiazem and lignocaine. primary outcome will be visual acuity pain score and amount of analgesics used.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: Double blinded trial
Primary Purpose: Treatment
Official Title: A Multi-arm Randomized Clinical Trial on Combination Topical Analgesia Post-haemorrhoidectomy: a Study on Metronidazole, Diltiazem and Lignocaine.
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Arm Intervention/treatment
Active Comparator: Metronidazole
Group A receiving 10% metronidazole cream
Drug: Metronidazole cream
10% metronidazole applied rectally

Active Comparator: Metronidazole + Diltiazem
Metronidazole 10% + Diltiazem 2%
Other: Combination Metronidazole and Diltiazem
Combination Metronidazole and Diltiazem applied rectally

Active Comparator: Metronidazole + Lignocaine
Metronidazole 10% + Lignocaine 4%
Other: Combination Metronidazole and Lignocaine
Combination metronidazole and lignocaine applied rectally

Active Comparator: Metronidazole + Diltiazem + Lignocaine
Metronidazole 10% + Diltiazem 2% + Lignocaine 4%
Drug: Combination Metronidazole, Diltiazem and Lignocaine
Combination of all active agents tested applied rectally




Primary Outcome Measures :
  1. Pain scores [ Time Frame: day 4 ]
    Measured by Visual acuity score, 1-10 the higher the score, the worse the pain

  2. Amount of analgesic use [ Time Frame: day 4 ]
    Morphine equivalent amount


Secondary Outcome Measures :
  1. Before and after Microbiome analysis [ Time Frame: day 4 ]
    rectal swab taken to analyse the microbiome of wound size


Other Outcome Measures:
  1. Validation of Haemorrhoid Severity Score [ Time Frame: Before surgery and 6 weeks post surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age ≥16
  • All patients undergoing excisional haemorrhoidectomy

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276298


Contacts
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Contact: James Jin, MBChB 6421 0235 1160 james.jin@auckland.ac.nz

Sponsors and Collaborators
University of Auckland, New Zealand

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Responsible Party: Andrew G Hill, MBChB, MD (Thesis), EdD, FACS, FRACS, Professor of Surgery, Head of School, University of Auckland, New Zealand
ClinicalTrials.gov Identifier: NCT04276298    
Other Study ID Numbers: APH MDL
First Posted: February 19, 2020    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Will be shared when results become available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: When results are available for 12 months
Access Criteria: email request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Metronidazole
Lidocaine
Diltiazem
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers