The Use of Topical Anaesthetic in the Banding of Internal Haemorrhoids
- Registration Number
- NCT04031131
- Lead Sponsor
- Julie Dawson
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- Symptomatic grade 1-3 haemorrhoid disease, 18+ years old, English is the first language.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Arm Instillagel topical anaesthetic gel and lubricating gel Intervention Arm KY Gel topical anaesthetic gel and lubricating gel Control Arm KY Gel lubricating gel alone
- Primary Outcome Measures
Name Time Method Patient recruitment rate 5 months Patient recruitment rate via screening log.
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.
Patient retention 5 months Patient retention via recruitment log.
- Secondary Outcome Measures
Name Time Method 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.
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.
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.
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.
Trial Locations
- Locations (1)
Norfolk & Norwich University Hospitals NHS Foundation Trust
🇬🇧Norwich, Norfolk, United Kingdom