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Completed

NCT Number: NCT05032508

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cochin hospital

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaïne Aguettant 20 mg/ml

Drug

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%

Drug

Placebo (NaCl 0,9%), applied to the skin with an impregnated compress, applied 15 minutes before infiltration performed by an experienced operator.

Primary outcomes

  1. Average pain intensity during the ultrasound-guided infiltration.

    Time frame: Day 0, immadiately after infiltration

    Evaluation assessed by self-administered pain numeric rating scale (0, no pain and 100, maximum pain).

Secondary outcomes

  1. Adverse Events

    Time frame: Day 0

    Adverse events based on a self-administered open-ended question

  2. Pain acceptance level in patients with trigger finger during the ultrasound-guided infiltration

    Time frame: 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).

  3. Pain acceptance level assessed by the operator during the ultrasound-guided infiltration of trigger finger

    Time frame: Day 0

    Pain acceptance will be assessed according to the operator, on a scale (0, not at all acceptable and 100, completely acceptable).

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Fondation de l'Avenir
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study 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)

Acronym: SAUTYLO

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 2, 2021
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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