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

Pontificia Universidad Catolica de Chile

Status and phase: Completed; Phase 3

Conditions: Pain; Hemorrhoids

Treatments: Drug: Placebo; Drug: Topical 2,5% lidocaine + 2,5% prilocaine gel

Study type: Interventional

Funder types: Other

Identifiers

NCT02130830

14-038

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Topical anesthesia

Experimental group

Description:

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

Treatment:

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

Placebo

Placebo Comparator group

Description:

Application of placebo gel into the anal canal before the procedure

Treatment:

Drug: Placebo