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Trigger Finger Corticosteroid Injection With and Without Local Anesthetic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04023695
Recruitment Status : Completed
First Posted : July 17, 2019
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Brian Drolet, Vanderbilt University Medical Center

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

Condition or disease Intervention/treatment Phase
Trigger Finger Drug: Corticosteroid with lidocaine with epinephrine Drug: Corticosteroid with normal saline Phase 4

Detailed Description:
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trigger Finger Corticosteroid Injection With and Without Local Anesthetic; a Randomized, Double Blind Controlled Trial
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : August 30, 2018
Actual Study Completion Date : August 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
Active Comparator: Corticosteroid with lidocaine with epinephrine
This arm includes an injection mixture of corticosteroid and lidocaine with epinephrine
Drug: Corticosteroid with lidocaine with epinephrine
Trigger finger injection

Experimental: 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.
Drug: Corticosteroid with normal saline
Trigger finger injection




Primary Outcome Measures :
  1. Pain outcome: visual analog scale [ Time Frame: Assessed 1 minute after injection (in clinic) ]
    Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever

  2. Pain outcome: visual analog scale [ Time Frame: Assessed after 24 hours after injection (by phone) ]
    Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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): NCT04023695


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37235
Sponsors and Collaborators
Vanderbilt University Medical Center

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Responsible Party: Brian Drolet, Assistant Professor Department of Plastic Surgery, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT04023695     History of Changes
Other Study ID Numbers: 1064521-12
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Trigger Finger Disorder
Tendon Entrapment
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Lidocaine
Epinephrine
Racepinephrine
Anesthetics, Local
Anesthetics
Epinephryl borate
Central Nervous System Depressants
Physiological Effects of Drugs
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
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics