Trigger Thumb Randomized Controlled Trial

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Trigger Thumb

Treatments: Procedure: Administration of Marcaine without Epinephrine prior to the start of surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03873480

18-015288

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: Under 4 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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31 participants in 2 patient groups

Intervention Arm

Active Comparator group

Description:

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.

Treatment:

Procedure: Administration of Marcaine without Epinephrine prior to the start of surgery

Non-Intervention Arm

No Intervention group

Description:

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.