The Use of Topical Anaesthetic in the Banding of Internal Haemorrhoids

NCT04031131 | Completed Phase 2

• 1 other identifier: 258546
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhoids

Keywords

Haemorrhoid; Banding; Topical Anaesthetic

Outcome Measures

Primary Outcomes (3)

• Patient recruitment rate

  Patient recruitment rate via screening log.

  5 months

• 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

• Patient retention

  Patient retention via recruitment log.

  5 months

Secondary Outcomes (4)

• Assess if the intervention reduced pain associated with haemorrhoids up to 72 hours after the procedure,

  72 hours

• Assess if the intervention reduces vasovagal symptoms up to 72 hours after the procedure

  72 hours

• Assess if the intervention reduced oral analgesia burden following the procedure

  72 hours

• Assess hospital readmission 1 month after the procedure.

  1 month

Study Arms (2)

Intervention Arm

ACTIVE COMPARATOR

topical anaesthetic gel and lubricating gel

Drug: Instillagel; Other: KY Gel

Control Arm

PLACEBO COMPARATOR

lubricating gel alone

Other: KY Gel

Interventions

Instillagel DRUG

Topical Anaesthetic Gel (Instillagel) licensed for rectal administration.

Intervention Arm

KY Gel OTHER

Lubricant Gel

Control Arm; Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Julie Dawson: lead

Study Sites (1)

Norfolk & Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 16719998 BACKGROUND

• 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.

  PMID: 12744096 BACKGROUND

• 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.

  PMID: 23323626 BACKGROUND

• 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.

  PMID: 10223757 BACKGROUND

• 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.

  PMID: 10211492 BACKGROUND

MeSH Terms

Conditions

Hemorrhoids

Interventions

chlorhexidine gluconate, lidocaine drug combination

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Vivek Sharma, Dr

  Foundation Year 1 Doctor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinded to assessors and patients
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Services Manager

Model Details: 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.

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 24, 2019
• Study Start: October 17, 2019
• Primary Completion: January 31, 2020
• Study Completion: March 1, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)