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Trigger Finger Corticosteroid Injection With and Without Local Anesthetic

NCT ID: NCT04023695

Last Updated: 2019-12-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2018-08-30

Brief Summary

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Steroid injection is the first line treatment for trigger finger. Steroid injection is sometimes mixed with a local anesthetic.

Detailed Description

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The treatment of trigger finger involves an injection of corticosteroid. Corticosteroid treats the underlying inflammatory pathology. Some surgeons add lidocaine with epinephrine as a local anesthetic with the injection. Lidocaine with epinephrine is associated with a burning sensation and may be the primary pain associated with the injection. We hypothesize that a corticosteroid injection without lidocaine with epinephrine will be less painful, and equally effective in treating trigger finger

Conditions

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Trigger Finger

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Corticosteroid with lidocaine with epinephrine

This arm includes an injection mixture of corticosteroid and lidocaine with epinephrine

Group Type ACTIVE_COMPARATOR

Corticosteroid with lidocaine with epinephrine

Intervention Type DRUG

Trigger finger injection

Corticosteroid with normal saline

This arm includes a mixture of corticosteroid and normal saline. The purpose of normal saline is the keep the volume and concentration similar when compared to the injections containing lidocaine.

Group Type EXPERIMENTAL

Corticosteroid with normal saline

Intervention Type DRUG

Trigger finger injection

Interventions

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Corticosteroid with lidocaine with epinephrine

Trigger finger injection

Intervention Type DRUG

Corticosteroid with normal saline

Trigger finger injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* At least 18 years old with trigger finger

Exclusion Criteria

* Preference for open trigger finger release
* Not a candidate for corticosteroid injection
* Contraindication to lidocaine with epinephrine
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Brian Drolet

Assistant Professor Department of Plastic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1064521-12

Identifier Type: -

Identifier Source: org_study_id