Clinical trial NCT05032508: Efficacy of the Application of Xylocaine Impregnated Compress in Reducing Per-procedural Pain During Ultrasound-guided Infiltration of Trigger Finger
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Trigger Finger
Keywords: Trigger Finger
Xylocaine
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Fondation de l'Avenir
First posted: 2021-09-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Average pain intensity during the ultrasound-guided infiltration.
timeFrame: Day 0, immadiately after infiltration
Secondary outcomes:
measure: Adverse Events
timeFrame: Day 0
measure: Pain acceptance level in patients with trigger finger during the ultrasound-guided infiltration
timeFrame: Day 0
measure: Pain acceptance level assessed by the operator during the ultrasound-guided infiltration of trigger finger
timeFrame: Day 0
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Henri GUERINI, MD
role: PRINCIPAL_INVESTIGATOR
References: