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

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)

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

Study Overview

• Status: Recruiting
• Conditions: Trigger Finger
• Intervention / Treatment: Drug: Lidocaïne Aguettant 20 mg/ml; Drug: NaCl 0,9%

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Henri GUERINI, MD; Phone Number: +33 1 58 41 25 02; Email: henri.guerini@aphp.fr

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Cochin Hospital
    • Contact: Henri GUERINI, MD; Phone Number: +33 1 58 41 25 02; Email: henri.guerini@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: 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.
Experimental: xylocaine	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average pain intensity during the ultrasound-guided infiltration.	Evaluation assessed by self-administered pain numeric rating scale (0, no pain and 100, maximum pain).	Day 0, immadiately after infiltration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Adverse events based on a self-administered open-ended question	Day 0
Pain acceptance level in patients with trigger finger during the ultrasound-guided infiltration	Pain acceptance will be assessed according to the patient himself on a self-administered scale (0, not at all acceptable and 100, completely acceptable).	Day 0
Pain acceptance level assessed by the operator during the ultrasound-guided infiltration of trigger finger	Pain acceptance will be assessed according to the operator, on a scale (0, not at all acceptable and 100, completely acceptable).	Day 0

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Fondation de l'Avenir
• Investigators: Principal Investigator: Henri GUERINI, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2022
• Primary Completion (Anticipated): June 7, 2023
• Study Completion (Anticipated): June 7, 2023

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: August 27, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Trigger Finger; Xylocaine
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Tendinopathy; Tendon Entrapment; Pain, Procedural; Trigger Finger Disorder; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: APHP210094; 2021-002052-36 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No