Efficacy of the Application of Xylocaine Impregnated Compress in Reducing Per-procedural Pain During Ultrasound-guided Infiltration of Trigger Finger
NCT ID: NCT05032508
Last Updated: 2022-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2022-06-07
2023-06-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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xylocaine
Lidocaïne 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.
Placebo
NaCl 0,9%
Placebo (NaCl 0,9%), applied to the skin with an impregnated compress, applied 15 minutes before infiltration performed by an experienced operator.
Interventions
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Lidocaïne 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.
NaCl 0,9%
Placebo (NaCl 0,9%), applied to the skin with an impregnated compress, applied 15 minutes before infiltration performed by an experienced operator.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Fondation de l'Avenir
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Henri GUERINI, MD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Cochin hospital
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-002052-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
APHP210094
Identifier Type: -
Identifier Source: org_study_id
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