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

NCT02130830 | Completed Phase 3

• 1 other identifier: 14-038
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

hemorrhoids; Rubber band ligation; pain

Outcome Measures

Primary Outcomes (1)

• Pain measured in analog visual scale

  up to 72 hours post procedure

Secondary Outcomes (1)

• Procedure morbidity

  up to 30 days post procedure

Other Outcomes (1)

• Pain measured in visual analog scale in subgroups

  up to 72 hours

Study Arms (2)

Topical anesthesia

EXPERIMENTAL

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

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

Placebo

PLACEBO COMPARATOR

Application of placebo gel into the anal canal before the procedure

Drug: Placebo

Interventions

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

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

Topical anesthesia

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic grade I - III hemorrhoidal disease

You may not qualify if:

• Chronic liver disease
• Use of class 3 antiarrythmics
• Coagulopathy
• Grade IV hemorrhoidal disease
• Inflammatory bowel disease
• Pregnancy

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Hospital Clínico Universidad Católica de Chile

Santiago, Santiago Metropolitan, 8330024, Chile

Location

MeSH Terms

Conditions

Hemorrhoids; Pain

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gellona Jose, MD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

• Bellolio Felipe, MD

  Pontificia Universidad Catolica de Chile

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: May 5, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 2, 2016

Record last verified: 2016-08

Locations

CL (1)