Topical Analgesia Post-Haemorrhoidectomy
- Conditions
- Hemorrhoid PainHemorrhoids
- Interventions
- Drug: Metronidazole, Diltiazem and Lidocaine cream
- Registration Number
- NCT04276298
- Lead Sponsor
- University of Auckland, New Zealand
- 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 following haemorrhoidectomy is known by all to be a miserable experience and current treatment is not very effective. We have formulated a new cream treatment which targets three theorised mechanisms of pain after haemorrhoidectomy. We will test the effectiveness of the treatments with a multi-centred randomised controlled factorial trial with four parallel double-blinded arms containing different combinations of the active agents. The outcomes include pain scores, amount of analgesia required and time to return to work. The results of our study could provide evidence of an effective treatment for post haemorrhoidectomy pain. The treatment may provide considerable benefit to patients undergoing this surgical procedure.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 192
- Age ≥16
- All patients undergoing excisional haemorrhoidectomy
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Metronidazole + Diltiazem Metronidazole and Diltiazem cream Metronidazole 10% + Diltiazem 2% Metronidazole + Lignocaine Metronidazole and Lidocaine cream Metronidazole 10% + Lignocaine 4% Metronidazole Metronidazole cream Group A receiving 10% metronidazole cream Metronidazole + Diltiazem + Lignocaine Metronidazole, Diltiazem and Lidocaine cream Metronidazole 10% + Diltiazem 2% + Lignocaine 4%
- Primary Outcome Measures
Name Time Method Amount of analgesic use 7 days Morphine equivalent amount
Pain scores 7 days Measured by visual analog scale, 1-10cm, continuous, the higher the score, the worse the pain
- Secondary Outcome Measures
Name Time Method Pain on bowel motion: Visual Analog Scale 7 days Measured by Visual Analog Scale, continuous 1-10cm, the higher the score, the worse the pain.
Complications 30 days Rates of Bleeding
Re-admission 30 days Rates of Re-admission to hospital,
Return to work 14 days Day post-operation when the patient returns to work
Repeat Prescription 30 days Rates of Repeat Prescription Requirement
Trial Locations
- Locations (1)
Counties Manukau District Health Board
🇳🇿Auckland, New Zealand