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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02130830
Recruitment Status : Completed
First Posted : May 5, 2014
Last Update Posted : August 2, 2016
Sponsor:
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

Study Description
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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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids
Drug Information available for: Prilocaine

Arms and Interventions
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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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02130830


Locations
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Chile
Hospital Clínico Universidad Católica de Chile
Santiago, Región Metropolitana, Chile, 8330024
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
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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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Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT02130830    
Other Study ID Numbers: 14-038
First Posted: May 5, 2014    Key Record Dates
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:
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Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Lidocaine
Anesthetics
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