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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Active Comparator | 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. |
|
| Non-Intervention Arm | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of Marcaine without Epinephrine prior to the start of surgery | Procedure | The intervention is the timing of administration of marcaine without epinephrine during a trigger thumb surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Apurva S Shah, MD, MBA | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
Deidentified individual participant data will not be made available.
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| ID | Term |
|---|---|
| D052582 | Trigger Finger Disorder |
| ID | Term |
|---|---|
| D053682 | Tendon Entrapment |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| 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. | 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. | 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. | 3 years |