Trigger Thumb Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Trigger Thumb
• Interventions: Procedure: Administration of Marcaine without Epinephrine prior to the start of surgery

• Registration Number: NCT03873480
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-02
• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-11
• Study First Posted: 2019-03-13
• Primary Completion: 2020-11-10
• Study Completion: 2020-11-10
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-15
• Last Update Posted: 2022-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Administration of Marcaine without Epinephrine prior to the start of surgery	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.

Primary Outcome Measures

Name	Time	Method
Difference in administered anesthesia	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

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

Trial Locations

Locations (1)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States