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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
38
Topical Anaesthetic Gel (Instillagel) licensed for rectal administration.
Lubricant Gel
Norfolk & Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, United Kingdom
Patient recruitment rate
Patient recruitment rate via screening log.
Time frame: 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.
Time frame: 5 months
Patient retention
Patient retention via recruitment log.
Time frame: 5 months
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.
Time frame: 72 hours
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.
Time frame: 72 hours
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.
Time frame: 72 hours
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 1 month