A comparison of 2 different medicated ointments with placebo for pain relief after banding of haemorrhoids.

A 3-arm Randomised, Double-blind, Placebo-controlled Trial of Lignocaine vs Lignocaine+Diltiazem vs Placebo Topical Ointments to Reduce Post-Procedural Pain in Patients Undergoing Haemorrhoidal Banding

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620000044921

Enrollment

Registered

2020-01-21

Start date

2021-03-03

Completion date

2021-10-08

Last updated

2021-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Haemorrhoidal symptoms are among the commonest complaints of mankind, it can occur in up to 80% of the population, involving any age and affecting both males and females equally. Surgical haemorrhoidectomy is most commonly used for 3rd or 4th degree haemorrhoids. However, surgery is associated with severe postoperative pain that is a source of such anxiety that some patients decide not to undergo the operation. Due to this, another non-surgical method can be used such as rubber band ligation, however this still requires pain relief. Research has suggested that current forms of pain relief are short term, caused more pain. Therefore, topical local anaesthetic agents are the next appealing option although have not been as successful as anticipated. Lignocaine in combination with Diltiazem are options that have not been used in this area and could potentially be more effective in relieving pain. This trial will examine the role of diltiazem and lignocaine in reducing post-procedure pain.

Interventions

The interventions consist of 3 different ointments: -lignocaine 2% in polyethylene glycol (PEG) base or -lignocaine 2% and diltiazem 2% in polyethylene glycol (PEG) base A 2cm length of ointment will be digitally applied to the anal area 3 times per day for 5 days from the procedure. Each participant will record in a written diary that the ointment has been applied.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients aged 18 years and over who present to the colorectal outpatient clinic or the private rooms of participating surgeons with symptomatic haemorrhoids suitable for banding will be considered for inclusion and offered study information.

Exclusion criteria

A person will be excluded if they have the following: • Coexisting anorectal disease such as anal fissure, fistula in ano, perianal abscess, thrombosed haemorrhoids, or colorectal malignancy • A current medical history of uncontrolled ischemic heart disease, heart block, pregnancy or currently breastfeeding, severe hypertension (systolic blood pressure greater than 180mmHg), or orthostatic hypotension • Poor general condition (i.e ASA classification 4 or 5) • Allergy or sensitivity to diltiazem, lignocaine or polyethylene glycol (PEG) USP ointment base • Current calcium channel blocker use • Known side effects from previous calcium channel blocker use • Refuse or are unable to give written informed consent to participate in the study.

Outcome results