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

NCT ID: NCT02130830

Last Updated: 2016-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-05-31

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.

Conditions

Hemorrhoids; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Topical anesthesia

Application of topical 2,5% lidocaine + 2,5% prilocaine gel to the anal canal before the procedure

Group Type: EXPERIMENTAL

Topical 2,5% lidocaine + 2,5% prilocaine gel

Intervention Type: DRUG

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

Placebo

Application of placebo gel into the anal canal before the procedure

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Topical 2,5% lidocaine + 2,5% prilocaine gel

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gellona Jose, MD

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica de Chile

Bellolio Felipe, MD

Role: STUDY_CHAIR

Pontificia Universidad Catolica de Chile

Locations

Hospital Clínico Universidad Católica de Chile

Santiago, Santiago Metropolitan, Chile

Countries

Chile

Other Identifiers

14-038

Identifier Type: -

Identifier Source: org_study_id