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

Trigger Finger Clinical Trial

— SAUTYLO  

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05032508
• Other study ID #: APHP210094
• Secondary ID: 2021-002052-36
• Status: Recruiting
• Phase: Phase 4
• Start date: June 7, 2022
• Est. completion date: June 7, 2023

Study information

• Verified date: September 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Henri GUERINI, MD
• Phone: +33 1 58 41 25 02
• Email: henri.guerini[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 7, 2023
• Est. primary completion date: June 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Procedural
• Trigger Finger
• Trigger Finger Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Cochin hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Fondation de l'Avenir

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse Events	Adverse events based on a self-administered open-ended question	Day 0
Secondary	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
Secondary	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