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

Phase 4

Recruiting

• Conditions: Trigger Finger
• Interventions: Drug: NaCl 0,9%; Drug: Lidocaïne Aguettant 20 mg/ml

• Registration Number: NCT05032508
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2021-08-27
• Study First Submitted QC: 2021-08-27
• Study First Posted: 2021-09-02
• Study Start: 2022-06-07
• Status Verified: 2022-09
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-08
• Primary Completion: 2023-06-07
• Study Completion: 2023-06-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	NaCl 0,9%	-
xylocaine	Lidocaïne Aguettant 20 mg/ml	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cochin hospital; 🇫🇷 Paris, France