The Use of Topical Anaesthetic in the Banding of Internal Haemorrhoids (TAB)

Julie Dawson

Status and phase: Completed; Phase 2

Conditions: Hemorrhoids

Treatments: Other: KY Gel; Drug: Instillagel

Study type: Interventional

Funder types: Other

Identifiers

NCT04031131

258546

Details and patient eligibility

About

The investigators' aim is to assess if they can complete a study measuring the effect of local anaesthetic gel (Instillagel) on reducing pain experienced by patients undergoing a common treatment for haemorrhoids (piles). This treatment is called rubber band ligation and is commonly performed in the investigators'clinics.

Full description

A feasibility trial assessing patient recruitment, retention, randomization, and surgeon acceptability of topical anaesthetic use during rubber band ligation of haemorrhoids.

A patient and assessor blinded feasibility trial. The trial population will prospectively be recruited from colorectal surgery outpatients. Patients will be randomized to two groups to receive: lubricating gel (K-Y Jelly) and topical anaesthetic gel (Instillagel) or lubricating gel alone (the standard care).

The intervention group will receive lubricating gel and topical anaesthetic gel (containing lidocaine active ingredient) administered rectally, whilst the control group will receive lubricating gel alone (standard care). This will be carried out in Colorectal Outpatients. The band ligation of the haemorrhoids should occur between 5-10 minutes after administration of the topical anaesthetic/lubricating gel. Pain scores and the use of oral analgesia will be measured immediately after the procedure (5 minutes), upon leaving the clinic (approximately 30 minutes after), at 4 hours, and 72 hours following the procedure. Vasovagal symptoms or other complications will be recorded whilst the patient is in the clinic. At 1 month post procedure, patients will be phoned to determine if any adverse events have occurred.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Symptomatic grade 1-3 haemorrhoid disease, 18+ years old, English is the first language.

Exclusion criteria

• Allergy to active ingredients of Instillagel, Allergy to local anaesthetic, Chronic liver disease, Grade 4 haemorrhoid disease, Pregnancy, Inflammatory bowel disease, Pre-existing anorectal disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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38 participants in 2 patient groups, including a placebo group

Intervention Arm

Active Comparator group

Description:

topical anaesthetic gel and lubricating gel

Treatment:

Drug: Instillagel

Other: KY Gel

Control Arm

Placebo Comparator group

Description:

lubricating gel alone

Treatment:

Other: KY Gel