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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Hemorrhoids; Pain	Drug: Topical 2,5% lidocaine + 2,5% prilocaine gel; Drug: Placebo	Phase 3

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	80 participants
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.
Study Start Date :	May 2014
Actual Primary Completion Date :	May 2016
Actual Study Completion Date :	May 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Other Outcome Measures:

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

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:	NCT02130830 History of Changes
Other Study ID Numbers:	14-038
First Posted:	May 5, 2014
Last Update Posted:	August 2, 2016
Last Verified:	August 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