TAB: The Use of Topical Anaesthetic in the Banding of Internal Haemorrhoids

• Sponsor: Julie Dawson (Other)
• Overall Status: Completed
• CT.gov ID: NCT04031131
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.5
• Patients Per Site Per Month: 8.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemorrhoids	Drug: Instillagel; Other: KY Gel	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• 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.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.
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Blinded to assessors and patients
• Primary Purpose: Treatment
• Official Title: The Use of Topical Anaesthetic in the Banding (TAB) of Internal Haemorrhoids: A Feasibility Study.
• Actual Study Start Date: Oct 17, 2019
• Actual Primary Completion Date: Jan 31, 2020
• Actual Study Completion Date: Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention Arm topical anaesthetic gel and lubricating gel	Drug: Instillagel; Topical Anaesthetic Gel (Instillagel) licensed for rectal administration.; Other: KY Gel; Lubricant Gel
Placebo Comparator: Control Arm lubricating gel alone	Other: KY Gel; Lubricant Gel

Outcome Measures

Primary Outcome Measures

1. Patient recruitment rate [5 months]

   Patient recruitment rate via screening log.

2. Treatment acceptability to patients [5 months]

   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.

3. Patient retention [5 months]

   Patient retention via recruitment log.

Secondary Outcome Measures

1. Assess if the intervention reduced pain associated with haemorrhoids up to 72 hours after the procedure, [72 hours]

   Assess if the intervention reduced pain associated with haemorrhoids up to 72 hours after the procedure via study questionnaire.

2. Assess if the intervention reduces vasovagal symptoms up to 72 hours after the procedure [72 hours]

   Assess if the intervention reduces vasovagal symptoms up to 72 hours after the procedure via study questionnaire.

3. Assess if the intervention reduced oral analgesia burden following the procedure [72 hours]

   Assess if the intervention reduced oral analgesia burden following the procedure via study questionnaire.

4. Assess hospital readmission 1 month after the procedure. [1 month]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Norfolk & Norwich University Hospitals NHS Foundation Trust	Norwich	Norfolk	United Kingdom	NR4 7UY

Sponsors and Collaborators

• Julie Dawson

Investigators

• Principal Investigator: Vivek Sharma, Dr, Foundation Year 1 Doctor

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Julie Dawson, Research Services Manager, Norfolk and Norwich University Hospitals NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT04031131
• Other Study ID Numbers: 258546
• First Posted: Jul 24, 2019
• Last Update Posted: Oct 8, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Julie Dawson, Research Services Manager, Norfolk and Norwich University Hospitals NHS Foundation Trust: Haemorrhoid; Banding; Topical Anaesthetic
• Additional relevant MeSH terms: Hemorrhoids

Study Results

No Results Posted as of Oct 8, 2020