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OpenTrials
Completed

NCT Number: NCT02130830

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

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.

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Key information

Conditions

Hemorrhoids Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Clínico Universidad Católica de Chile

Santiago, Santiago Metropolitan, 8330024, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Pain measured in analog visual scale

    Time frame: up to 72 hours post procedure

Secondary outcomes

  1. Procedure morbidity

    Time frame: up to 30 days post procedure

Other outcomes

  1. Pain measured in visual analog scale in subgroups

    Time frame: up to 72 hours

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 5, 2014
Registry last updated
Aug 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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