Trigger Thumb Randomized Controlled Trial

Children's Hospital of Philadelphia31 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Trigger Thumb

Interventions

Administration of Marcaine without Epinephrine prior to the start of surgeryPROCEDURE

The intervention is the timing of administration of marcaine without epinephrine during a trigger thumb surgery.

Eligibility

Sex: ALLMin age: 0 YearsMax age: 4 Years

Medical Language ↔ Plain English

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.

Locations (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 3 years

Secondary Outcomes

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 3 years

Data from ClinicalTrials.gov

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