Topical Analgesia Post-Haemorrhoidectomy

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Auckland, New Zealand
• Treatments: Diltiazem; Lidocaine; Metronidazole

Criteria

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.