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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pontificia Universidad Catolica de Chile

ClinicalTrials.gov Identifier:

NCT02130830

First received: May 1, 2014

Last updated: August 1, 2016

Last verified: August 2016

History of Changes

Purpose

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.

Condition	Intervention	Phase
Hemorrhoids Pain	Drug: Topical 2,5% lidocaine + 2,5% prilocaine gel Drug: Placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Hemorrhoids

U.S. FDA Resources

Further study details as provided by Pontificia Universidad Catolica de Chile:

Primary Outcome Measures:

Pain measured in analog visual scale [ Time Frame: up to 72 hours post procedure ]

Secondary Outcome Measures:

Procedure morbidity [ Time Frame: up to 30 days post procedure ]

Other Outcome Measures:

Pain measured in visual analog scale in subgroups [ Time Frame: up to 72 hours ]


Enrollment:	80
Study Start Date:	May 2014
Study Completion Date:	May 2016
Primary Completion Date:	May 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02130830

Locations


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

Sponsors and Collaborators

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

More Information


Responsible Party:	Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:	NCT02130830 History of Changes
Other Study ID Numbers:	14-038
Study First Received:	May 1, 2014
Last Updated:	August 1, 2016

Keywords provided by Pontificia Universidad Catolica de Chile:


hemorrhoids Rubber band ligation pain

Additional relevant MeSH terms:


Hemorrhoids Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Vascular Diseases Cardiovascular Diseases Anesthetics Lidocaine Prilocaine	Central Nervous System Depressants Physiological Effects of Drugs Anesthetics, Local Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 21, 2017

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