Status:
COMPLETED
Topical Analgesia Post-Haemorrhoidectomy
Lead Sponsor:
University of Auckland, New Zealand
Conditions:
Hemorrhoid Pain
Hemorrhoids
Eligibility:
All Genders
16+ years
Phase:
PHASE2
PHASE3
Brief Summary
Symptomatic haemorrhoids, or piles, have significant effects on quality of life. The treatment for advanced disease is surgical excision (haemorrhoidectomy) which is extremely effective. However, pain...
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 ...
Eligibility Criteria
Inclusion
- Age ≥16
- All patients undergoing excisional haemorrhoidectomy
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2022
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT04276298
Start Date
September 1 2020
End Date
February 1 2022
Last Update
May 18 2022
Active Locations (1)
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1
Counties Manukau District Health Board
Auckland, New Zealand, 1041