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

August 1, 2016 updated by: Pontificia Universidad Catolica de Chile

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile, 8330024
        • Hospital Clínico Universidad Católica de Chile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Topical anesthesia
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
The topical gel is administered in the anal canal at the moment of the anoscopy
PLACEBO_COMPARATOR: Placebo
Application of placebo gel into the anal canal before the procedure
Drug: Placebo
Placebo gel to mimic topical anesthesia administered in the anal canal at the moment of the anoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain measured in analog visual scale
Time Frame: up to 72 hours post procedure
up to 72 hours post procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Procedure morbidity
Time Frame: up to 30 days post procedure
up to 30 days post procedure

Other Outcome Measures

Outcome Measure
Time Frame
Pain measured in visual analog scale in subgroups
Time Frame: up to 72 hours
up to 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Investigators

  • Principal Investigator: Gellona Jose, MD, Pontificia Universidad Catolica de Chile
  • Study Chair: Bellolio Felipe, MD, Pontificia Universidad Catolica de Chile

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

May 1, 2014

First Submitted That Met QC Criteria

May 2, 2014

First Posted (ESTIMATE)

May 5, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

August 2, 2016

Last Update Submitted That Met QC Criteria

August 1, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-038

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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