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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-002052-36 | EudraCT Number |
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| Name | Class |
|---|---|
| Fondation de l'Avenir | OTHER |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The purpose of this study is to assess the efficacy of Xylocaine impregnated compress in reducing per-procedural pain during ultrasound-guided infiltration of Trigger Finger
Trigger finger ultrasound-guided infiltrations are frequent and painful invasive procedures.
However, there is no current recommendation for per-procedural pain management, and in the majority of cases, infiltration is performed without prior skin anesthesia.
Xylocaine patches are of controversial efficacy in pain acute management. In current practice, they are not prescribed in advance and they are not well adapted to the topography of the finger.
On the other hand, a recent study showed the interest of administering lidocaine 2% by J-tip, a needle-free injection technique not available in France, before infiltration of Trigger Finger.
The investigators hypothesize that an impregnated compress in Xylocaine 20 mg/ml injectable solution, applied 15 minutes before the procedure, would reduce per-procedural pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| xylocaine | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaïne Aguettant 20 mg/ml | Drug | Lidocaïne Aguettant 20 mg/ml, injectable solution, applied to the skin with an impregnated compress, applied 15 minutes before infiltration performed by an experienced operator. |
| Measure | Description | Time Frame |
|---|---|---|
| Average pain intensity during the ultrasound-guided infiltration. | Evaluation assessed by self-administered pain numeric rating scale (0, no pain and 100, maximum pain). | Day 0, immadiately after infiltration |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Adverse events based on a self-administered open-ended question | Day 0 |
| Pain acceptance level in patients with trigger finger during the ultrasound-guided infiltration | Pain acceptance will be assessed according to the patient himself on a self-administered scale (0, not at all acceptable and 100, completely acceptable). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henri GUERINI, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cochin hospital | Paris | 75014 | France |
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| NaCl 0,9% | Drug | Placebo (NaCl 0,9%), applied to the skin with an impregnated compress, applied 15 minutes before infiltration performed by an experienced operator. |
|
| Day 0 |
| Pain acceptance level assessed by the operator during the ultrasound-guided infiltration of trigger finger | Pain acceptance will be assessed according to the operator, on a scale (0, not at all acceptable and 100, completely acceptable). | Day 0 |
| ID | Term |
|---|---|
| D052582 | Trigger Finger Disorder |
| ID | Term |
|---|---|
| D053682 | Tendon Entrapment |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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