Topical Anesthesia Versus Placebo to Decrease Pain in Rubber Band Ligation for Treatment of Internal Hemorrhoids
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| ClinicalTrials.gov Identifier: NCT02130830 |
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Recruitment Status :
Completed
First Posted : May 5, 2014
Last Update Posted : August 2, 2016
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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 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Topical anesthesia
Application of topical 2,5% lidocaine + 2,5% prilocaine gel to the anal canal before the procedure
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Drug: Topical 2,5% lidocaine + 2,5% prilocaine gel
The topical gel is administered in the anal canal at the moment of the anoscopy |
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Placebo Comparator: Placebo
Application of placebo gel into the anal canal before the procedure
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Drug: Placebo
Placebo gel to mimic topical anesthesia administered in the anal canal at the moment of the anoscopy |
- Pain measured in analog visual scale [ Time Frame: up to 72 hours post procedure ]
- Procedure morbidity [ Time Frame: up to 30 days post procedure ]
- Pain measured in visual analog scale in subgroups [ Time Frame: up to 72 hours ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| Chile | |
| Hospital Clínico Universidad Católica de Chile | |
| Santiago, Región Metropolitana, Chile, 8330024 | |
| Principal Investigator: | Gellona Jose, MD | Pontificia Universidad Catolica de Chile | |
| Study Chair: | Bellolio Felipe, MD | Pontificia Universidad Catolica de Chile |
| 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 Key Record Dates |
| Last Update Posted: | August 2, 2016 |
| Last Verified: | August 2016 |
Keywords provided by Pontificia Universidad Catolica de Chile:
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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 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 |