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

NCT05032508 | Completed Phase 4

• 2 other identifiers: APHP2100942021-002052-36
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Trigger Finger

Keywords

Trigger Finger; Xylocaine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Adverse Events

  Day 0

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

  Day 0

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

  Day 0

Study Arms (2)

xylocaine

EXPERIMENTAL

Drug: Lidocaïne Aguettant 20 mg/ml

Placebo

PLACEBO COMPARATOR

Drug: NaCl 0,9%

Interventions

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.

xylocaine

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Fondation de l'Avenir: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Cochin hospital

Paris, 75014, France

Location

MeSH Terms

Conditions

Trigger Finger Disorder

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Henri GUERINI, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 2, 2021
• Study Start: June 7, 2022
• Primary Completion: June 7, 2023
• Study Completion: June 7, 2023
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

FR (1)