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

A

Assistance Publique - Hôpitaux de Paris

Status and phase

Enrolling
Phase 4

Conditions

Trigger Finger

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05032508
2021-002052-36 (EudraCT Number)
APHP210094

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups, including a placebo group

xylocaine
Experimental group
Treatment:
Drug: Lidocaïne Aguettant 20 mg/ml
Placebo
Placebo Comparator group
Treatment:
Drug: NaCl 0,9%

Trial contacts and locations

1

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Central trial contact

Laetitia PEAUDECERF, PhD; Henri GUERINI, MD

Data sourced from clinicaltrials.gov

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