Efficacy of the Application of Xylocaine Impregnated Compress in Reducing Per-procedural Pain During Ultrasound-guided Infiltration of Trigger Finger (SAUTYLO)
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| ClinicalTrials.gov Identifier: NCT05032508 |
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Recruitment Status :
Recruiting
First Posted : September 2, 2021
Last Update Posted : November 8, 2022
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Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborator:
Fondation de l'Avenir
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
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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 |
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 Type : | Interventional (Clinical Trial) |
| Estimated 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) |
| Actual Study Start Date : | June 7, 2022 |
| Estimated Primary Completion Date : | June 7, 2023 |
| Estimated Study Completion Date : | June 7, 2023 |
Resource links provided by the National Library of Medicine
| 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. |
Primary Outcome Measures :
- Average pain intensity during the ultrasound-guided infiltration. [ Time Frame: Day 0, immadiately after infiltration ]Evaluation assessed by self-administered pain numeric rating scale (0, no pain and 100, maximum pain).
Secondary Outcome Measures :
- Adverse Events [ Time Frame: 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 [ Time Frame: 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).
- Pain acceptance level assessed by the operator during the ultrasound-guided infiltration of trigger finger [ Time Frame: Day 0 ]Pain acceptance will be assessed according to the operator, on a scale (0, not at all acceptable and 100, completely acceptable).
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05032508
Contacts
| Contact: Henri GUERINI, MD | +33 1 58 41 25 02 | henri.guerini@aphp.fr | |
| Contact: Laetitia PEAUDECERF, PhD | +33 1 58 41 12 13 | laetitia.peaudecerf@aphp.fr |
Locations
| France | |
| Cochin hospital | Recruiting |
| Paris, France, 75014 | |
| Contact: Henri GUERINI, MD +33 1 58 41 25 02 henri.guerini@aphp.fr | |
| Contact: Christelle Nguyen, MD, PhD +33 1 58 41 29 45 christelle.nguyen2@aphp.fr | |
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Fondation de l'Avenir
Investigators
| Principal Investigator: | Henri GUERINI, MD | Assistance Publique - Hôpitaux de Paris |
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT05032508 |
| Other Study ID Numbers: |
APHP210094 2021-002052-36 ( EudraCT Number ) |
| First Posted: | September 2, 2021 Key Record Dates |
| Last Update Posted: | November 8, 2022 |
| Last Verified: | September 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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:
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Trigger Finger Xylocaine |
Additional relevant MeSH terms:
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Trigger Finger Disorder Pain, Procedural Pain Neurologic Manifestations Tendon Entrapment Tendinopathy Muscular Diseases Musculoskeletal Diseases Lidocaine Anesthetics, Local |
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |