Efficacy of the Application of Xylocaine Impregnated Compress in Reducing Per-procedural Pain During Ultrasound-guided Infiltration of Trigger Finger

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Efficacy of the Application of Xylocaine Impregnated Compress in Reducing Per-procedural Pain During Ultrasound-guided Infiltration of Trigger Finger: a Randomized, Double-blind Controlled Study (SAUTYLO)

Conditions
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Trigger Finger

Intervention / Treatment
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* Drug: Lidocaïne Aguettant 20 mg/ml
* Drug: NaCl 0,9%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 years or older Trigger Finger (clinically defined by painful difficulty or protrusion when extending the finger) with an ultrasound-guided infiltration of cortisone derivatives indication. Written consent Affiliation to a Social Security system Prior medical examination Exclusion Criteria: Neurological conditions affecting the hand other than carpal tunnel syndrome Intra-articular infiltration of the hand or the wrist ≤ 2 months Allergy to Xylocaine Contraindication to Xylocaine or cortisone derivatives Cognitive or behavioral disorders that make assessment impossible Persons referred to in articles L 1121-5; 6; 8; 9 of the Public Health Code (protected adults, under guardianship or curatorship, etc) Pregnancy and breastfeeding; absence of contraceptive method for women of childbearing age Participant unable to speak, read and write French

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: xylocaine<br> | Drug: Lidocaïne Aguettant 20 mg/ml<br>* 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.<br>|
| Placebo Comparator: Placebo<br> | Drug: NaCl 0,9%<br>* Placebo (NaCl 0,9%), applied to the skin with an impregnated compress, applied 15 minutes before infiltration performed by an experienced operator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trigger Finger, Xylocaine