NCT02130830

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

Topical Anesthesia Versus Placebo to Decrease Post Procedure Pain in Rubber Band Ligation for the Treatment of Grade I - III Symptomatic Internal Hemorrhoids. A Single Institution, Double Blinded, Placebo Controlled Trial.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Pontificia Universidad Catolica de Chile · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemorrhoids
• Pain

Interventions

Type	Name	Description
DRUG	Topical 2,5% lidocaine + 2,5% prilocaine gel	The topical gel is administered in the anal canal at the moment of the anoscopy
DRUG	Placebo	Placebo gel to mimic topical anesthesia administered in the anal canal at the moment of the anoscopy

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2014-05-05
• Last updated: 2016-08-02

Locations

1 site across 1 country: Chile