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

Primary Purpose

Hemorrhoids, Pain

Status

Completed

Phase

Phase 3

Locations

Chile

Study Type

Interventional

Intervention

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

Placebo

About this trial

This is an interventional treatment trial for Hemorrhoids focused on measuring hemorrhoids, Rubber band ligation, pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hospital Clínico Universidad Católica de Chile

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Topical anesthesia

Placebo

Arm Description

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

Application of placebo gel into the anal canal before the procedure

Outcomes

Primary Outcome Measures

Pain measured in analog visual scale

Secondary Outcome Measures

Procedure morbidity

Full Information

NCT ID

NCT02130830

First Posted

May 1, 2014

Last Updated

August 1, 2016

Sponsor

Pontificia Universidad Catolica de Chile

1. Study Identification

Unique Protocol Identification Number

NCT02130830

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pontificia Universidad Catolica de Chile

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemorrhoids, Pain

Keywords

hemorrhoids, Rubber band ligation, pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Topical anesthesia

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Application of placebo gel into the anal canal before the procedure

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Pain measured in analog visual scale

Time Frame

up to 72 hours post procedure

Secondary Outcome Measure Information:

Title

Procedure morbidity

Time Frame

up to 30 days post procedure

Other Pre-specified Outcome Measures:

Title

Pain measured in visual analog scale in subgroups

Time Frame

up to 72 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gellona Jose, MD

Organizational Affiliation

Pontificia Universidad Catolica de Chile

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Bellolio Felipe, MD

Organizational Affiliation

Pontificia Universidad Catolica de Chile

Official's Role

Study Chair

Facility Information:

Facility Name

Hospital Clínico Universidad Católica de Chile

City

Santiago

State/Province

Región Metropolitana

ZIP/Postal Code

8330024

Country

Chile

12. IPD Sharing Statement

Learn more about this trial

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

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