- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02130830
Topical Anesthesia Versus Placebo to Decrease Pain in Rubber Band Ligation for Treatment of Internal Hemorrhoids
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Región Metropolitana
-
Santiago, Región Metropolitana, Chile, 8330024
- Hospital Clínico Universidad Católica de Chile
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Topical anesthesia
Application of topical 2,5% lidocaine + 2,5% prilocaine gel to the anal canal before the procedure
|
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
|
Placebo gel to mimic topical anesthesia administered in the anal canal at the moment of the anoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain measured in analog visual scale
Time Frame: up to 72 hours post procedure
|
up to 72 hours post procedure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Procedure morbidity
Time Frame: up to 30 days post procedure
|
up to 30 days post procedure
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain measured in visual analog scale in subgroups
Time Frame: up to 72 hours
|
up to 72 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gellona Jose, MD, Pontificia Universidad Catolica de Chile
- Study Chair: Bellolio Felipe, MD, Pontificia Universidad Catolica de Chile
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Gastrointestinal Diseases
- Intestinal Diseases
- Rectal Diseases
- Hemorrhoids
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
- Prilocaine
Other Study ID Numbers
- 14-038
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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