Hemorrhoids, Pain
Conditions
Keywords
hemorrhoids, Rubber band ligation, pain
Brief summary
Rubber band ligation is a simple and effective procedure for the management of hemorrhoidal disease. However, 90% of patients have some degree of discomfort associated with the procedure and up to 40% develop clinically significant pain. Some studies have used local anesthesia to reduce pain with promising results, but the use of topical anesthesia has not been reported before. The investigators hypothesize that the use of topical anesthesia before rubber band ligation significantly reduces post procedure pain.
Interventions
DRUGTopical 2,5% lidocaine + 2,5% prilocaine gel
The topical gel is administered in the anal canal at the moment of the anoscopy
DRUGPlacebo
Placebo gel to mimic topical anesthesia administered in the anal canal at the moment of the anoscopy
Sponsors
Pontificia Universidad Catolica de Chile
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptomatic grade I - III hemorrhoidal disease
Exclusion criteria
* Chronic liver disease * Use of class 3 antiarrythmics * Coagulopathy * Grade IV hemorrhoidal disease * Inflammatory bowel disease * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain measured in analog visual scale | up to 72 hours post procedure |
Secondary
| Measure | Time frame |
|---|---|
| Procedure morbidity | up to 30 days post procedure |
Other
| Measure | Time frame |
|---|---|
| Pain measured in visual analog scale in subgroups | up to 72 hours |
Countries
Chile
Outcome results
None listed