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Trigger Thumb Randomized Controlled Trial

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03873480
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Apurva Shah, Children's Hospital of Philadelphia

Brief Summary:
We are conducting this study to determine if administration of local anesthetic to the thumb prior to surgery can reduce the amount of anesthetic gas given during the course of surgery.

Condition or disease Intervention/treatment Phase
Trigger Thumb Procedure: Administration of Marcaine without Epinephrine prior to the start of surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Administration of Local Anesthetic in Trigger Thumb Surgery: A Randomized Clinical Trial
Actual Study Start Date : October 2, 2018
Estimated Primary Completion Date : September 18, 2021
Estimated Study Completion Date : September 18, 2021


Arm Intervention/treatment
Active Comparator: Intervention Arm
Participants randomized into the intervention group will receive an injection of 2.5 cc of 0.25% marcaine without epinephrine prior to the incision. The local anesthetic will be administered by the treating surgeon. All other aspects of the procedure will be kept in accordance with the standard of care for trigger thumb surgeries.
Procedure: Administration of Marcaine without Epinephrine prior to the start of surgery
The intervention is the timing of administration of marcaine without epinephrine during a trigger thumb surgery.

No Intervention: Non-Intervention Arm
Those that are not randomized into the intervention group will receive the standard of care for a trigger thumb release, which is administration of 2.5 cc of 0.25% marcaine without epinephrine following completion of surgery. The local anesthetic will be administered by the treating surgeon.



Primary Outcome Measures :
  1. Difference in administered anesthesia [ Time Frame: 3 years ]
    The primary outcome will be the difference in administered gaseous sevoflurane during the course of trigger thumb surgery between the control group and intervention group.


Secondary Outcome Measures :
  1. Difference in observed pain score [ Time Frame: 3 years ]

    The secondary outcome will be the difference in observed pain scores during the post-operative period following a trigger thumb surgery between the control group and intervention group. The FLACC (face, legs, activity, consolability) Behavioural pain scale will be used. There are 5 components, e.g. face, legs, activity, cry, and consolability, that are given a grade of 0, 1, or 2. The sum of the each component grade will give the pain scale score.

    0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain


  2. Difference in operative time [ Time Frame: 3 years ]
    The secondary outcome will be the difference in operative time during the course of a trigger thumb surgery between the control group and intervention group.

  3. Difference in length of stay [ Time Frame: 3 years ]
    The secondary outcome will be the difference in total length of study following a trigger thumb surgery between the control group and intervention group.

  4. Difference in complication rates [ Time Frame: 3 years ]
    The secondary outcome will be the difference in complication rates following a trigger thumb surgery between the control group and intervention group.



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Ages Eligible for Study:   up to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females, age 0-4 years, presenting to the CHOP Department of Orthopaedics with unilateral trigger thumb that requires surgical treatment.
  2. ASA Classification of 1 or 2.
  3. Parental/guardian permission (informed consent).

Exclusion Criteria:

  1. Males or females over the age of 4.
  2. ASA Classification higher than 2.
  3. Patients presenting with systemic diseases or significant comorbidities.
  4. Patients that received treatment for trigger thumb at an outside institution.

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): NCT03873480


Contacts
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Contact: Fairs Z Fazal, BS 215-590-1522 ext 41522 fazalf@email.chop.edu
Contact: Divya Talwar, PhD, MPH 215-590-7841 ext 47841 talward@email.chop.edu

Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Matthew Buczek, BS    215-590-0991 ext 40991    buczekm@email.chop.edu   
Principal Investigator: Apurva S Shah, MD, MBA         
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
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Principal Investigator: Apurva S Shah, MD, MBA Children's Hospital of Philadelphia

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Responsible Party: Apurva Shah, Assistant Professor of Orthopaedic Surgery, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03873480    
Other Study ID Numbers: 18-015288
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Trigger Finger Disorder
Tendon Entrapment
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Epinephrine
Racepinephrine
Anesthetics
Bupivacaine
Anesthetics, Local
Epinephryl borate
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents