Hemorrhoid Pain, Hemorrhoids
Conditions
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.
Interventions
10% metronidazole applied rectally
DRUGMetronidazole and Diltiazem cream
Combination Metronidazole and Diltiazem applied rectally
DRUGMetronidazole and Lidocaine cream
Combination metronidazole and lignocaine applied rectally
DRUGMetronidazole, Diltiazem and Lidocaine cream
Combination of all active agents tested applied rectally
Sponsors
University of Auckland, New Zealand
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Double blinded trial, both participant and investigator are blinded.
Intervention model description
Parallel with 1:1:1:1 Allocation.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores | 7 days | Measured by visual analog scale, 1-10cm, continuous, the higher the score, the worse the pain |
| Amount of analgesic use | 7 days | Morphine equivalent amount |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Repeat Prescription | 30 days | Rates of Repeat Prescription Requirement |
| Complications | 30 days | Rates of Bleeding |
| 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. |
| Return to work | 14 days | Day post-operation when the patient returns to work |
| Re-admission | 30 days | Rates of Re-admission to hospital, |
Countries
New Zealand
Outcome results
None listed