drugset / Trial / NCT04276298

Topical Analgesia Post-Haemorrhoidectomy

NCT04276298

Phase 2/3 Completed 192 enrolled University of Auckland, New Zealand
RandomizedFactorialDouble-blindTreatment

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.

Timeline

Start
2020-09-01
Primary completion
2022-02-01
Completion
2022-02-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Diltiazem Small molecule 2 % Rectal
Comparator Lidocaine Other / unclassified 4 % Rectal
Comparator Metronidazole Small molecule 10 % Rectal

Indications