Trigger Thumb Randomized Controlled Trial

Administration of Local Anesthetic in Trigger Thumb Surgery: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Trigger Thumb
• Intervention / Treatment: Procedure: Administration of Marcaine without Epinephrine prior to the start of surgery

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 4 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Males or females, age 0-4 years, presenting to the Children's Hospital of Philadelphia (CHOP) Department of Orthopaedics with unilateral trigger thumb that requires surgical treatment.
2. American Society of Anaesthesiologists (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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in administered anesthesia	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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in observed pain score	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	3 years
Difference in operative time	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 years
Difference in length of stay	The secondary outcome will be the difference in total length of study following a trigger thumb surgery between the control group and intervention group.	3 years
Difference in complication rates	The secondary outcome will be the difference in complication rates following a trigger thumb surgery between the control group and intervention group.	3 years

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Apurva S Shah, MD, MBA, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 2, 2018
• Primary Completion (ACTUAL): November 10, 2020
• Study Completion (ACTUAL): November 10, 2020

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: March 11, 2019
• First Posted (ACTUAL): March 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Tendinopathy; Tendon Entrapment; Trigger Finger Disorder; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Bupivacaine; Epinephrine
• Other Study ID Numbers: 18-015288

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Deidentified individual participant data will not be made available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No