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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02130830
First Posted: May 5, 2014
Last Update Posted: August 2, 2016
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.
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile
  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:


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

Information from the National Library of Medicine

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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
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
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
First Submitted: May 1, 2014
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