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

Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02130830
• Other study ID #: 14-038
• Status: Completed
• Phase: Phase 3
• First received: May 1, 2014
• Last updated: August 1, 2016
• Start date: May 2014
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Instituto de Salud Pública de Chile
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhoids
• Pain

Intervention

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

Locations

Country	Name	City	State
Chile	Hospital Clínico Universidad Católica de Chile	Santiago	Región Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain measured in visual analog scale in subgroups		up to 72 hours	No
Primary	Pain measured in analog visual scale		up to 72 hours post procedure	No
Secondary	Procedure morbidity		up to 30 days post procedure	No