The Use of Topical Anaesthetic in the Banding of Internal Haemorrhoids

Hemorrhoids Clinical Trial

— TAB  

Official title:

The Use of Topical Anaesthetic in the Banding (TAB) of Internal Haemorrhoids: A Feasibility Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04031131
• Other study ID #: 258546
• Status: Completed
• Phase: Phase 2
• Start date: October 17, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: October 2020
• Source: Norfolk and Norwich University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 1, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhoids

Intervention

Drug:
• Instillagel
Topical Anaesthetic Gel (Instillagel) licensed for rectal administration.

Other:
• KY Gel
Lubricant Gel

Locations

Country	Name	City	State
United Kingdom	Norfolk & Norwich University Hospitals NHS Foundation Trust	Norwich	Norfolk

Sponsors (1)

Lead Sponsor	Collaborator
Julie Dawson

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient recruitment rate	Patient recruitment rate via screening log.	5 months
Primary	Treatment acceptability to patients	Treatment acceptability to patients via study questionnaire. A visual analogue scale to be used, 0 - 10 with '0' being no pain and '10' being worst pain possible.	5 months
Primary	Patient retention	Patient retention via recruitment log.	5 months
Secondary	Assess if the intervention reduced pain associated with haemorrhoids up to 72 hours after the procedure,	Assess if the intervention reduced pain associated with haemorrhoids up to 72 hours after the procedure via study questionnaire.	72 hours
Secondary	Assess if the intervention reduces vasovagal symptoms up to 72 hours after the procedure	Assess if the intervention reduces vasovagal symptoms up to 72 hours after the procedure via study questionnaire.	72 hours
Secondary	Assess if the intervention reduced oral analgesia burden following the procedure	Assess if the intervention reduced oral analgesia burden following the procedure via study questionnaire.	72 hours
Secondary	Assess hospital readmission 1 month after the procedure.	Assess hospital readmission 1 month after the procedure via review of hospital notes. The number of patients requiring additional analgesia will be compared between the two groups.	1 month