Trigger Thumb Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

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

Conditions
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Trigger Thumb

Intervention / Treatment
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* Procedure: Administration of Marcaine without Epinephrine prior to the start of surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. American Society of Anaesthesiologists (ASA) Classification of 1 or 2. Parental/guardian permission (informed consent). Exclusion Criteria: Males or females over the age of 4. ASA Classification higher than 2. Patients presenting with systemic diseases or significant comorbidities. Patients that received treatment for trigger thumb at an outside institution.

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Arm<br>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<br>* The intervention is the timing of administration of marcaine without epinephrine during a trigger thumb surgery.<br>|
| No Intervention: Non-Intervention Arm<br>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?
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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 |