Trigger FingerPhase 4SAUTYLONCT05032508
Efficacy of the Application of Xylocaine Impregnated Compress in Reducing Per-procedural Pain During Ultrasound-guided Infiltration of Trigger Finger
A Phase 4 study testing Lidocaïne Aguettant 20 mg/ml and NaCl 0,9% in people with Trigger Finger, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigger Finger
- What is being tested?
- Lidocaïne Aguettant 20 mg/ml and NaCl 0,9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2022to 7 Jun 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
Read the 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.
- Conditions
- Trigger Finger
- Being tested
- Lidocaïne Aguettant 20 mg/ml, NaCl 0,9%
- Keywords
- Trigger Finger, Xylocaine
- Medical subject headings
- Trigger Finger Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaïne Aguettant 20 mg/mlDrug
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%Drug
Placebo (NaCl 0,9%), applied to the skin with an impregnated compress, applied 15 minutes before infiltration performed by an experienced operator.
| Study group | Role | What they receive |
|---|---|---|
| xylocaine | Experimental | Not described Receives: Drug: Lidocaïne Aguettant 20 mg/ml |
| Placebo | Placebo comparator | Not described Receives: Drug: NaCl 0,9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average pain intensity during the ultrasound-guided infiltration.
Evaluation assessed by self-administered pain numeric rating scale (0, no pain and 100, maximum pain).
Measured: Day 0, immadiately after infiltration
Secondary outcomes (3)
Adverse Events
Adverse events based on a self-administered open-ended question
Measured: Day 0
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).
Measured: Day 0
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).
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start7 Jun 2022
- Primary completion7 Jun 2023
- Study completion7 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger FingerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de l'Avenir, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Henri GUERINI, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032508
- Sponsor's protocol ID
- APHP210094
- Other IDs
- 2021-002052-36
- Acronym
- SAUTYLO
- Status last verified
- Apr 2026
- First submitted
- 27 Aug 2021
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05032508
- Acronym / sponsor ID
- SAUTYLO / APHP210094
- Conditions
- Trigger Finger
- Keywords
- Trigger Finger, Xylocaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fondation de l'Avenir, URC-CIC Paris Descartes Necker Cochin
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 7 Jun 2023 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| xylocaine | Experimental | Drug: Lidocaïne Aguettant 20 mg/ml |
| Placebo | Placebo comparator | Drug: NaCl 0,9% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaïne Aguettant 20 mg/mlLidocaïne Aguettant 20 mg/ml, injectable solution, applied to the skin with an impregnated compress, applied 15 minutes before infiltration performed by an experienced operator. | Drug | xylocaine |
| 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. | Drug | Placebo |
Primary outcome
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).
3 secondary outcomes
Adverse Events
Time frame: Day 0
Pain acceptance level in patients with trigger finger during the ultrasound-guided infiltration
Time frame: Day 0
Pain acceptance level assessed by the operator during the ultrasound-guided infiltration of trigger finger
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Trigger Finger
Recruiting
A Clinical Study to Compare Functional Outcomes After Surgery Using a Transverse or Longitudinal Surgical Incision in the Skin.
Functional Disturbance as Result
Recruiting
Low-Level Laser Therapy in the Treatment of Trigger Finger
Trigger Finger, Stenosing Tenosynovitis
Not yet recruiting
Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test
Non-traumatic Musculoskeletal Conditions, Carpal Tunnel Syndrome (CTS)
Enrolling by invitation
A Comparison of Metacarpophalangeal Joint Blocking Splint With Relative Motion Extension Splint for Trigger Finger
Trigger Finger
RecruitingPhase 4
Ketorolac in Upper Extremity Tendinopathy and Arthropathy
Osteoarthritis, Tendinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henri GUERINI, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaïne Aguettant 20 mg/ml and NaCl 0,9% in people with Trigger Finger, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average pain intensity during the ultrasound-guided infiltration. (time frame: Day 0, immadiately after infiltration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.