Trigger Finger
Conditions
Keywords
Trigger Finger, Xylocaine
Brief summary
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
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.
Interventions
DRUGLidocaïne Aguettant 20 mg/ml
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.
DRUGNaCl 0,9%
Placebo (NaCl 0,9%), applied to the skin with an impregnated compress, applied 15 minutes before infiltration performed by an experienced operator.
Sponsors
Fondation de l'Avenir
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average pain intensity during the ultrasound-guided infiltration. | Day 0, immadiately after infiltration | Evaluation assessed by self-administered pain numeric rating scale (0, no pain and 100, maximum pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Day 0 | Adverse events based on a self-administered open-ended question |
| Pain acceptance level in patients with trigger finger during the ultrasound-guided infiltration | Day 0 | Pain acceptance will be assessed according to the patient himself on a self-administered scale (0, not at all acceptable and 100, completely acceptable). |
| Pain acceptance level assessed by the operator during the ultrasound-guided infiltration of trigger finger | Day 0 | Pain acceptance will be assessed according to the operator, on a scale (0, not at all acceptable and 100, completely acceptable). |
Countries
France
Contacts
Primary ContactHenri GUERINI, MD
Backup ContactLaetitia PEAUDECERF, PhD
Outcome results
None listed