Topical Anesthesia Versus Placebo to Decrease Pain in Rubber Band Ligation for Treatment of Internal Hemorrhoids

Pontificia Universidad Catolica de Chile80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Hemorrhoids Pain

Interventions

The topical gel is administered in the anal canal at the moment of the anoscopy

PlaceboDRUG

Placebo gel to mimic topical anesthesia administered in the anal canal at the moment of the anoscopy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Clínico Universidad Católica de Chile

Santiago, Santiago Metropolitan, Chile

Outcomes

Primary Outcomes

Pain measured in analog visual scale

Time frame: up to 72 hours post procedure

Secondary Outcomes

Procedure morbidity

Time frame: up to 30 days post procedure

Data from ClinicalTrials.gov

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