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

Primary Purpose

Trigger Finger

Status
Recruiting
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Lidocaïne Aguettant 20 mg/ml
NaCl 0,9%
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Trigger Finger focused on measuring Trigger Finger, Xylocaine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cochin hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

xylocaine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse Events
Adverse events based on a self-administered open-ended question
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).
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).

Full Information

First Posted
August 27, 2021
Last Updated
November 4, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Fondation de l'Avenir
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1. Study Identification

Unique Protocol Identification Number
NCT05032508
Brief Title
Efficacy of the Application of Xylocaine Impregnated Compress in Reducing Per-procedural Pain During Ultrasound-guided Infiltration of Trigger Finger
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2022 (Actual)
Primary Completion Date
June 7, 2023 (Anticipated)
Study Completion Date
June 7, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Fondation de l'Avenir

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Finger
Keywords
Trigger Finger, Xylocaine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
xylocaine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lidocaïne Aguettant 20 mg/ml
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
NaCl 0,9%
Intervention Description
Placebo (NaCl 0,9%), applied to the skin with an impregnated compress, applied 15 minutes before infiltration performed by an experienced operator.
Primary Outcome Measure Information:
Title
Average pain intensity during the ultrasound-guided infiltration.
Description
Evaluation assessed by self-administered pain numeric rating scale (0, no pain and 100, maximum pain).
Time Frame
Day 0, immadiately after infiltration
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Adverse events based on a self-administered open-ended question
Time Frame
Day 0
Title
Pain acceptance level in patients with trigger finger during the ultrasound-guided infiltration
Description
Pain acceptance will be assessed according to the patient himself on a self-administered scale (0, not at all acceptable and 100, completely acceptable).
Time Frame
Day 0
Title
Pain acceptance level assessed by the operator during the ultrasound-guided infiltration of trigger finger
Description
Pain acceptance will be assessed according to the operator, on a scale (0, not at all acceptable and 100, completely acceptable).
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Henri GUERINI, MD
Phone
+33 1 58 41 25 02
Email
henri.guerini@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Laetitia PEAUDECERF, PhD
Phone
+33 1 58 41 12 13
Email
laetitia.peaudecerf@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henri GUERINI, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cochin hospital
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henri GUERINI, MD
Phone
+33 1 58 41 25 02
Email
henri.guerini@aphp.fr
First Name & Middle Initial & Last Name & Degree
Christelle Nguyen, MD, PhD
Phone
+33 1 58 41 29 45
Email
christelle.nguyen2@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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