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

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05032508
• Collaborator: Fondation de l'Avenir (Other)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Trigger Finger	Drug: Lidocaïne Aguettant 20 mg/ml; Drug: NaCl 0,9%	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Supportive Care
• 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)
• Anticipated Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.
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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Adverse Events [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 [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 [Day 0]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cochin hospital	Paris		France	75014

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris
• Fondation de l'Avenir

Investigators

• Principal Investigator: Henri GUERINI, MD, Assistance Publique - Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT05032508
• Other Study ID Numbers: APHP210094; 2021-002052-36
• First Posted: Sep 2, 2021
• Last Update Posted: Mar 10, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Assistance Publique - Hôpitaux de Paris: Trigger Finger; Xylocaine
• Additional relevant MeSH terms: Trigger Finger Disorder; Pain, Procedural; Lidocaine

Study Results

No Results Posted as of Mar 10, 2022