Trigger Thumb Randomized Controlled Trial

Trigger Thumb Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03873480
• Other study ID #: 18-015288
• Status: Completed
• Phase: N/A
• Start date: October 2, 2018
• Est. completion date: November 10, 2020

Study information

• Verified date: September 2022
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 10, 2020
• Est. primary completion date: November 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 4 Years

Eligibility

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.

Related Conditions & MeSH terms

• Trigger Finger Disorder
• Trigger Thumb

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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