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

Phase 3

Completed

• Conditions: Pain; Hemorrhoids
• Interventions: Drug: Topical 2,5% lidocaine + 2,5% prilocaine gel; Drug: Placebo

• Registration Number: NCT02130830
• Lead Sponsor: Pontificia Universidad Catolica de Chile

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-01
• Study First Submitted QC: 2014-05-02
• Study First Posted: 2014-05-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-01
• Last Update Posted: 2016-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Topical anesthesia	Topical 2,5% lidocaine + 2,5% prilocaine gel	Application of topical 2,5% lidocaine + 2,5% prilocaine gel to the anal canal before the procedure
Placebo	Placebo	Application of placebo gel into the anal canal before the procedure

Primary Outcome Measures

Name	Time	Method
Pain measured in analog visual scale	up to 72 hours post procedure

Secondary Outcome Measures

Name	Time	Method
Procedure morbidity	up to 30 days post procedure

Trial Locations

Locations (1)

Hospital Clínico Universidad Católica de Chile; 🇨🇱 Santiago, Región Metropolitana, Chile