Topical Analgesia Post-Haemorrhoidectomy

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04276298
Study type	Interventional
Source	University of Auckland, New Zealand
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	September 1, 2020
Completion date	February 1, 2022

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT02851940` - Pain and Bleeding Following Hypertonic Saline Sclerotherapy Compared to Brand Ligation for Symptomatic Hemorrhoids	N/A
Recruiting	`NCT02301052` - Evaluation of Allium Ampeloprasum Spp.Iranicum Cream Effect for the Management of Hemorrhoids Symptoms	Phase 1/Phase 2
Completed	`NCT02216305` - HAL-RAR Versus Hemorrhoidectomy in the Treatment of Grade III-IV Hemorrhoids. Prospective, Randomized Trial	N/A
Completed	`NCT02358174` - Hemorrhoids and Metalloproteinases, Observational Study	N/A
Completed	`NCT01483833` - Efficacy Study of Iferanserin to Treat Hemorrhoids	Phase 2
Completed	`NCT00397137` - Stapled Anopexy Versus Closed Haemorrhoidectomy for Haemorrhoids	N/A
Completed	`NCT00841620` - Symptom Control 1-year After Circular Stapler Anopexy or Diathermy Excision for Prolapsed Haemorhoids	Phase 4
Completed	`NCT04675177` - Polidocanol Foam VS Artery Ligation in Hemorrhoidal Disease	Phase 2/Phase 3
Recruiting	`NCT05889962` - Ultrasound-guided Pudendal Nerve Block for Pain After Hemorrhoidectomy	N/A
Recruiting	`NCT01961739` - Topical 2% Lidocaine for the Treatment of Symptomatic Hemorrhoids	Phase 2/Phase 3
Active, not recruiting	`NCT02061176` - THD Versus Open Haemorrhoidectomy	N/A
Withdrawn	`NCT00512044` - Local Versus General Anaesthesia in Stapled Hemorrhoidectomy	Phase 4
Completed	`NCT04031131` - The Use of Topical Anaesthetic in the Banding of Internal Haemorrhoids	Phase 2
Recruiting	`NCT04329364` - RCT Comparing Conventional Haemorrhoidectomy With Laser Haemorrhoidoplasty	Phase 2/Phase 3
Completed	`NCT05247333` - Implementation of a Minor Ailment Service in Community Pharmacy Practice	N/A
Completed	`NCT04567485` - Impact of Moderate to Severe Pain in the Post-intervention Monitoring Room After Hemorrhoidectomy on the Length of Stay in the Outpatient Surgery Unit
Completed	`NCT03298997` - Ligation and Hemorrhoidopexy Technique Versus Ligation of Hemorrhoidal Arteries Using Ultrasound for Hemorrhoids	N/A
Completed	`NCT05605080` - Hemostatic and Analgesic Effect of Gel Foam and Gauze With Bosmin After Anal Surgery	N/A
Completed	`NCT03797703` - Efficacy of Lidocaine Gel Enema After Endoscopic Hemorrhoid Band Ligation for Relief of Post Procedural Pain	Phase 1
Completed	`NCT05157711` - Clinical Trial of Anusol Ointment for Symptom Relief in Patients With Haemorrhoids	Phase 3