Topical Anesthesia Versus Placebo to Decrease Pain in Rub... | NCT02130830

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

NCT02130830

Sponsor

Pontificia Universidad Catolica de Chile

Status

Completed

Last Update Posted

Aug 2, 2016Estimated

Enrollment

80Actual

Phase

Phase 3

Conditions

Hemorrhoids
Pain

Interventions

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

Countries

Chile

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

May 1, 2014

First Submission Date that Met QC Criteria

May 2, 2014

First Posted Date

May 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2016

Last Update Posted Date

Aug 2, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Topical anesthesia	Experimental	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
Placebo	Placebo Comparator	Application of placebo gel into the anal canal before the procedure	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Topical 2,5% lidocaine + 2,5% prilocaine gel	Drug	The topical gel is administered in the anal canal at the moment of the anoscopy	Topical anesthesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain measured in analog visual scale		up to 72 hours post procedure

Secondary Outcomes

Measure	Description	Time Frame
Procedure morbidity		up to 30 days post procedure

Other Outcomes

Measure	Description	Time Frame
Pain measured in visual analog scale in subgroups		up to 72 hours

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gellona Jose, MD	Pontificia Universidad Catolica de Chile	Principal Investigator
Bellolio Felipe, MD	Pontificia Universidad Catolica de Chile	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clínico Universidad Católica de Chile		Santiago	Santiago Metropolitan	8330024	Chile

Condition Browse Module

MeSH Terms

ID	Term
D006484	Hemorrhoids
D010146	Pain

Ancestor Terms

ID	Term
D012002	Rectal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided