Trigger Thumb
Conditions
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.
Interventions
PROCEDUREAdministration 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.
Sponsors
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
0 Years to 4 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed