Clinical trial NCT04031131: The Use of Topical Anaesthetic in the Banding of Internal Haemorrhoids
Official title: The Use of Topical Anaesthetic in the Banding (TAB) of Internal Haemorrhoids: A Feasibility Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hemorrhoids
Keywords: Haemorrhoid
Banding
Topical Anaesthetic
Lead sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-07-24
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The trial will be a randomised control trial blinded to patient and assessor (the clinician collecting data at 4 hours, 72 hours and 1 month after the procedure. Randomisation will be achieved by a computer software. Administrators will be aware of which group the patient being treated is in. Half of the patients (n=30) will receive the intervention treatment (Instillagel topical anaesthetic) and lubricating gel (standard of care), the other half will receive the standard of care alone (lubricating gel) (n=30) before the procedure. The standard of care is to use no form of analgesia, with K-Y gel only being used as a lubricant. Researchers will be asked to apply the allocated treatment 5-10 minutes before the procedure. The primary end points will be: patient recruitment rate, patient acceptability, surgeon acceptability, patient retention. The secondary endpoints will be: pain scores using the 10-point visual analogue scale.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient recruitment rate
timeFrame: 5 months
measure: Treatment acceptability to patients
timeFrame: 5 months
measure: Patient retention
timeFrame: 5 months
Secondary outcomes:
measure: Assess if the intervention reduced pain associated with haemorrhoids up to 72 hours after the procedure,
timeFrame: 72 hours
measure: Assess if the intervention reduces vasovagal symptoms up to 72 hours after the procedure
timeFrame: 72 hours
measure: Assess if the intervention reduced oral analgesia burden following the procedure
timeFrame: 72 hours
measure: Assess hospital readmission 1 month after the procedure.
timeFrame: 1 month
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich University Hospitals NHS Foundation Trust
state: Norfolk
Study officials:
affiliation: Foundation Year 1 Doctor
name: Vivek Sharma, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Watson NF, Liptrott S, Maxwell-Armstrong CA. A prospective audit of early pain and patient satisfaction following out-patient band ligation of haemorrhoids. Ann R Coll Surg Engl. 2006 May;88(3):275-9. doi: 10.1308/003588406X98649.
citation: Gokalp A, Baskonus I, Maralcan G. A prospective randomised study of local anaesthetic injection after multiple rubber band ligation of haemorrhoids. Chir Ital. 2003 Mar-Apr;55(2):213-7.
citation: Kwok HC, Noblett SE, Murray NE, Merrie AE, Hayes JL, Bissett IP. The use of local anaesthesia in haemorrhoidal banding: a randomized controlled trial. Colorectal Dis. 2013 Apr;15(4):487-91. doi: 10.1111/codi.12088.
citation: Law WL, Chu KW. Triple rubber band ligation for hemorrhoids: prospective, randomized trial of use of local anesthetic injection. Dis Colon Rectum. 1999 Mar;42(3):363-6. doi: 10.1007/BF02236354.
citation: Hooker GD, Plewes EA, Rajgopal C, Taylor BM. Local injection of bupivacaine after rubber band ligation of hemorrhoids: prospective, randomized study. Dis Colon Rectum. 1999 Feb;42(2):174-9. doi: 10.1007/BF02237123.